Airway fires in otolaryngologic surgery: A database review.

PURPOSE: An estimated 34 % of reported operating room fires involve the airway. Despite the inherent risks in otolaryngologic surgery, education regarding prevention and management of airway fires is limited in graduate medical training. One contributing factor is a lack of reporting of such rare events in our literature. METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to fires occurring during surgical procedures of the airway from January 1, 2010, to March 31, 2020. RESULTS: 3687 reports were identified and 49 unique reports of airway fire were included. Sustained fires were described in 16 (32.7 %) reports and 33 (67.3 %) described transient flares. 2 fires extended beyond the airway and 9 (18.4 %) were noted to have occurred at the start of the case. Fires were reported most commonly during tonsillectomy (n = 22 [44.9 %]), vocal fold excision (n = 5 [10.2 %]), and adenoidectomy (n = 4 [8.2 %]). 46 reports attributed flare initiation to a specific element of the fire triangle. 16 patient and 2 operator injuries were reported. Saline washing was utilized in 7 (14.3 %) cases overall. Patients were extubated immediately in 2 (12.5 %) of the 16 reports of sustained fires. 0 mortalities were reported. CONCLUSION: Airway fires were reported in a variety of upper airway procedures performed regularly by otolaryngologists. The triggering factor that led to fire was identified as a spark or char in about half of the reported cases, and only 2 reports described immediate removal of the endotracheal tube.

Cost-analysis of in-office versus operating room sialendoscopy: Comparison of cost burden and outcomes.

PURPOSE: Office-based procedures in otolaryngology are increasingly utilized to increase efficiency, reduce cost, and eliminate risks associated with surgery. Gland-preserving surgical management of sialadenitis and sialolithiasis are often performed in the operating room, although many surgeons are moving this practice to clinic. We aim to determine the difference in patient charges and perioperative outcomes for salivary gland procedures performed in the clinic versus the OR. METHODS: Retrospective series of patients presenting with sialolithiasis, acute or chronic sialadenitis, and stricture between 2010 and 2019. Demographics, perioperative variables, setting, and charge data were collected. RESULTS: 528 patients underwent operative intervention (n = 427 office, n = 101 OR). Cohort demographics were comparable. Sialolithiasis was the most common presenting diagnosis in both cohorts. Both cohorts had similar rates of complete (p = 0.09) and partial (p = 0.97) response to treatment. A higher percentage of patients in the OR group reported no improvement (21.4 vs 12.2%, p = 0.034). Overall complications were similar (p = 0.582). Mean charges were statistically greater in the OR ($5560.35 OR vs $1298.33 office, p < 0.001). Operative time was significantly reduced in the office group (21.8 min vs 60.85 min, p < 0.001). CONCLUSIONS: Appropriately selected patients can be successfully treated in outpatient clinic without compromising patient safety or quality while significantly reducing the financial burden to patients and the healthcare system.

Postoperative Complications After Thyroidectomy: Time Course and Incidence Before Discharge.

BACKGROUND: Although complication rates after thyroidectomy are well described in the literature, the timing of these events is less understood. This study delineates the timeline and risk factors for early adverse events after thyroidectomy. MATERIALS AND METHODS: This study included a retrospective review of 161,534 patients who underwent thyroidectomy between 2005 and 2018 using the American College of Surgeons National Surgical Quality Improvement Program database. Time to specific complications was analyzed for all patients undergoing thyroidectomy, with further stratification of hemithyroidectomy and total thyroidectomy cohorts. Univariate analyses were conducted to analyze demographics, preoperative comorbidities, and complications. A multivariate logistic regression model was generated to identify significant risk factors for 7-day postoperative complications. RESULTS: The overall complication rate was 3.28%. A majority of complications arose before discharge including the following: blood transfusion (96%), hematoma formation (68%), pneumonia (53%), and cardiac arrest (67%). Approximately 37% of unplanned reoperations occurred before discharge in the hemithyroidectomy versus 63% in the total thyroidectomy cohort. Greater than 65% of mortalities occurred after discharge in both groups. Complications generally occurring within 7 d for the entire cohort included the following: pneumonia (3; 2-8 [median postoperative day; interquartile range]), pulmonary embolism (6; 2-12), cardiac arrest (1; 0-5), myocardial infarction (2; 1-6), blood transfusions (0; 0-1), and hematoma formation (0; 0-2). Superficial surgical site infection (9; 6-16) occurred later. Patients who underwent outpatient surgery had a decreased risk of complications (odds ratio 0.41) in the 7-day postoperative period. CONCLUSIONS: Although early complications after thyroidectomy are rare, they have a distinct time course, many of which occur after discharge. However, in selected patients undergoing outpatient thyroidectomy, overall risk of complications is decreased. Understanding timing helps establish better preoperative communication and education to improve postoperative expectations for the provider and patient.

Adverse Effects of Chronic Steroid use Following Thyroidectomy.

BACKGROUND: Prior to thyroid surgery, a subset of patients chronically uses steroids to manage medical conditions such as Grave's disease, auto-immune conditions, or organ transplantation. Existing literature describes adverse effects of prolonged steroid use on surgical outcomes, however there remains a paucity of data investigating the specific effects of steroid use on postoperative outcomes after thyroidectomy. This study aims to identify complication risks steroid users are predisposed to after thyroidectomy. MATERIALS AND METHODS: The American College of Surgeons National Surgical Quality Improvement Program Database (ACS-NSQIP) was queried to identify and isolate all patients who had undergone thyroidectomy procedures by Current Procedure Terminology codes from 2005 through 2018. Univariate analysis was performed to compare steroid uses and non-steroid users. Coarsened exact matching was utilized to homogenize the two cohorts based on demographics and preoperative comorbidities. RESULTS: A total of 153,595 thyroidectomies were initially included. After Coarsened exact matching, 116,861 patients were categorized as non-steroid users, and 2,965 as steroid users. The steroid cohort demonstrated significantly higher rates of any complication (P < 0.001) as well as overall surgical, cardiopulmonary, and renal complications. Individual complications such as superficial surgical site infections (P = 0.013), pulmonary embolism (P = 0.016), deep vein thrombosis (P = 0.011), progressive renal insufficiency (P = 0.006), and unplanned readmission (P = 0.026) were also increased. CONCLUSIONS: Patients with chronic steroid use undergoing thyroidectomy are at an increased risk for surgical, cardiopulmonary, and renal complications. Further research on preoperative steroid management is necessary for optimizing outcomes in this population.

Complications associated with PlasmaBlade TnA during tonsillectomy and adenoidectomy from 2010 to 2020: A MAUDE study.

PURPOSE: The pulsed-electron avalanche knife (PEAK) PlasmaBlade TnA (Medtronic, n.d.) is a relatively new electrosurgical technology that is used widely in head and neck surgery (Medtronic Manuals, n.d.). This study aims to summarize device malfunctions, patient complications, and subsequent interventions related to PEAK PlasmaBlade TnA during tonsillectomy and adenoidectomy. MATERIALS AND METHODS: The US Food and Drug Administration's Manufacture and User Facility Device Experience database was queried for reports of PlasmaBlade TnA adverse events from June 6, 2009, to August 30, 2020. Data were extracted from reports pertaining to tonsillectomy with or without adenoidectomy. RESULTS: 128 reports were identified, from which 163 adverse events were extracted. Of these, 23 (14.6%) were related to patients, and 140 (85.4%) were related to device malfunction. The most frequently reported patient-related adverse event was a burn injury (17 [73.9%]). The most common device malfunctions were dislodgment of device component (39 [27.9%]), followed by tip ignition (32 [22.9%]), damaged tip or wire during operation (28 [20%]), and melted device (24 [17.1%]). CONCLUSIONS: PEAK PlasmaBlade TnA have demonstrated utility in tonsillectomy with or without adenoidectomy but are associated with adverse events. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further study is needed to clarify optimal approaches to education.

Efficacy of ethanol ablation as a treatment of benign head and neck cystic lesions.

OBJECTIVE: To evaluate the efficacy and safety of ethanol ablation in the treatment of benign head and neck cystic lesions. METHODS: A total of 25 patients who received ethanol ablation (EA) of head and neck cystic lesions by an otolaryngologist at a single institution between October 2017 and October 2020 were identified. Patient demographics, clinical characteristics, treatment details, and treatment outcomes at follow up visits were obtained by retrospective review of electronic medical records. RESULTS: 25 patients who underwent ethanol ablation of head and neck cystic lesions were included, with a mean age of 49.1 years old (Interquartile range (IQR),32.5-65.5 years) and 12 males (47.0%). The most common cysts treated with EA were thyroglossal duct cysts (n = 8, 32.0%) and lymphoepithelial parotid cysts (n = 7, 28.0%). The mean volume prior to treatment was 10.57 mL (IQR, 1.58-8.81 mL). Mean volume following EA was 1.30 mL (range, 0.10-0.97 mL) with 74.40% cyst reduction by volume (IQR, 48.56-96.29%) (p = 0.002). The mean time to the last follow-up was 5 months (range, 3-6 months). One patient received surgery despite treatment success to obtain a definitive diagnosis of the mass. No other patients received further surgical management. The treatment success of EA, as defined by >70% volume reduction or the resolution of symptoms, was 92.0%. All patients were satisfied with the outcome and had no reported complications. CONCLUSION: EA is an effective and safe alternative to surgery for the treatment of head and neck cystic lesions that can be performed in an outpatient setting by an otolaryngologist.

Obesity is a predictor of increased morbidity after tracheostomy.

OBJECTIVE: The purpose of this study was to analyze the relationship between body mass index (BMI) and 30-day morbidity and mortality risk in patients undergoing tracheostomy using the American College of Surgeons National Quality Improvement Program (ACS-NSQIP). STUDY DESIGN: This is a retrospective, cross-sectional, cohort study. SETTING: Patients were identified with Current Procedural Terminology codes in the ACS-NSQIP database. SUBJECTS AND METHODS: Patients who underwent tracheostomy from 2005 to 2018 were queried. They were stratified into four BMI classes and matched to normal BMI cohorts. Multivariate logistic regression was used to identify independent predictors for complications, readmissions, and unplanned reoperations within 30 days. RESULTS: Among 3784 patients meeting inclusion and exclusion criteria, obesity was shown to be a significant independent risk factor for overall complications (OR 1.439, 95% CI 1.226-1.689, p < 0.001), postoperative acute renal failure (OR 10.715, 95% CI 1.213-94.646, p = 0.033), and unplanned readmissions (OR 1.702, 95% CI 1.095-2.647, p = 0.018). A significantly lower rate of postoperative transfusions was observed for obese patients (OR 0.581, 95% CI 0.432-0.781, p < 0.001). CONCLUSIONS: Obesity was found to be independently associated with an increased risk of overall complication, developing acute renal failure, and having an unplanned 30-day readmission following tracheostomy. The risk of postoperative transfusion appears to be lower in obese patients. LEVEL OF EVIDENCE: 4.

Ultrasound-guided ethanol sclerotherapy for non-surgical treatment of Warthin's tumor.

BACKGROUND: Currently, the first line treatment for Warthin's tumor (WT) is parotidectomy. There is a paucity of data evaluating the safety and efficacy of non-surgical treatments for patients not amenable to surgery. Ultrasound guided ethanol sclerotherapy (UGES) has been successfully used for the management of lymphangiomans of the head and neck, thyroid nodules, and thyroid cysts. This is the first study to implement and assess the success of UGES for management of WT. METHODS: We report two patients with WT, with a total of 3 masses, who underwent UGES. All procedures were performed in the clinic. The primary outcome measured was the tumor volume reduction rate (VRR), patient satisfaction, and complications observed at follow-up. RESULTS: Both patients experienced a significant reduction in tumor size upon follow up. VRR for the three treated tumors were 67.30%, 98.32%, and 55.73%. Patient were very satisfied with the results and noted significant cosmetic improvement. No complications were observed at follow-up. CONCLUSIONS: Ultrasound guided ethanol sclerotherapy may be a viable option for conservative treatment of Warthin's tumor in patients unsuitable or unwilling to undergo surgical resection.

Adverse Events Associated with Implantable Dopplers during Microvascular Surgery.

BACKGROUND: Implantable Dopplers (IDs) are widely used for postoperative free flap vascular monitoring. However, IDs may contribute to free flap complications or failure and better understanding of device malfunctions is needed. METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for all reports of ID adverse events from two leading manufacturers (Cook Vascular and Synovis Life Technologies) in free flap surgery from January 2010 to March 2020. Reports were reviewed and categorized. A comparison of reoperations within select categories was performed using Chi-square analysis. RESULTS: Of 209 included reports, the most common device malfunctions were venous anastomotic coupler misalignment (35.4%) and coupler ring detachment (24.4%). Synovis devices were used in 100% of reports of vessel compression and Cook Vascular devices were used in 77.7% of reports of probe detachment. Of 74 patient-related adverse events, the most common were reoperation (47.3%) and vessel occlusion (28.4%). Of five reported events of flap failure, two were associated with loss of ID signal. The proportion of Doppler signal loss events leading to reoperation was significantly greater than the proportion of any other Doppler-related event leading to reoperation. Intraoperative coupler replacement was the most commonly reported intervention (n = 86), and venous anastomosis with hand-suturing occurred in 30 device malfunctions. CONCLUSION: This study demonstrates a variety of ID-related malfunctions. One-third of device malfunctions were associated with patient complications, and false-positive Doppler signal loss contributed substantially to the requirement of surgical re-exploration. These are important considerations for surgical teams utilizing IDs in free tissue transfer procedures.

Adverse events associated with the Inspire implantable hypoglossal nerve stimulator: A MAUDE database review.

BACKGROUND: Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12 months of therapy. OBJECTIVE: The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to HNS therapy that could hinder compliance. METHODS: A search of the FDA MAUDE database was conducted using the product code "MNQ" for "Inspire stimulator for sleep apnea." Reports of adverse events associated with Inspire for sleep apnea from January 2000 to May 2020 were included for analysis. From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. Results were compiled and reviewed. RESULTS: The search query yielded 180 reports that met inclusion criteria, containing a total of 196 adverse events. The most commonly reported adverse events to patients were infection (n = 50, 34.2%), neuropraxia (n = 22, 15.1%) and hematoma/seroma (n = 17, 11.6%). A total of 83 adverse events (42.3%) required reoperation. The most common reoperations performed for adverse events to patients were explantation (n = 30, 46.2%) and device repositioning/lead revision (n = 24, 36.9%), while the most common reoperation performed for device malfunctions was device replacement (n = 10, 55.6%). CONCLUSION: In attempting to further improve patient compliance, understanding these device malfunctions and adverse events related to HNS implantation or usage is crucial for the identification of potential causes of patient non-adherence.

Complications associated with tracheoesophageal voice prostheses from 2010 to 2020: A MAUDE study.

PURPOSE: Tracheoesophageal puncture with voice prosthesis placement remains the gold standard for voice restoration following total laryngectomy, but may cause various complications. This study aims to summarize patient-related and device-related adverse events associated with tracheoesophageal puncture and voice prosthesis placement. MATERIALS AND METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to tracheoesophageal puncture with voice prosthesis placement from January 1, 2010, to April 30, 2020. Data were extracted from reports pertaining to tracheoesophageal prostheses. RESULTS: Seventy-seven reports involving tracheoesophageal voice prostheses were identified, from which 111 adverse events were extracted. Of these, 58 (52.3%) were patient-related, while 53 (47.7%) were device-related. The most frequently reported patient-related adverse events were aspirated prosthesis (24 [41.4%]), foreign body during placement (11 [19.0%]), aspiration pneumonia (9 [15.5%]), and aspirated brush tip (8 [13.8%]). The most common device-related adverse events were detached brush tip (15 [28.3%]), leak (14 [26.4%]), and torn esophageal flange (11 [20.8%]). CONCLUSIONS: While tracheoesophageal puncture with voice prosthesis placement has revolutionized voice rehabilitation following total laryngectomy, the procedure may be associated with adverse events both at the time of placement and later. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further research is needed to clarify optimal approaches to education.

Salivary gland ultrasound training: Improving anatomic identification in residents.

OBJECTIVES/HYPOTHESIS: The aim of the study was to introduce and study the role of standardized views for ultrasound of the major salivary glands in resident learning and retention. STUDY DESIGN: Methods description and prospective case series. METHODS: Five otolaryngology residents and two patient models were recruited for this study. The participants were timed on their identification of the submandibular gland, sublingual gland, and parotid gland and associated key anatomic structures. Participants were then timed again immediately after being presented a standardized view for each salivary gland: the longitudinal submandibular gland, transverse parotid gland, and submental transverse views. The same participants were then timed one month later to determine retention. A Wilcoxon signed-rank test was used to evaluate whether time to identification was equal pre- and post-standardized view instruction. RESULTS: There was a significant improvement from pre- to post-standardized view instruction in all glands, which was sustained one month later. Practically speaking, assessment times for all participants at the one-month measurement were reasonable, with averages of 71, 42, and 114 s for the submandibular gland, sublingual gland, and parotid gland respectively. CONCLUSIONS: Standardized views provided otolaryngology ultrasonography learners with a reliable, fast, and memorable way to assess the salivary glands and their related structures. LEVEL OF EVIDENCE: 4.

Otolaryngology-related Google Search trends during the COVID-19 pandemic.

OBJECTIVE: To assess trends of Google Search queries for symptoms and complaints encountered commonly in otolaryngology practices during the coronavirus disease 2019 (COVID-19) pandemic when in-person care has been limited. MATERIALS AND METHODS: In this cross-sectional study, data on Google Search queries in the United States for 30 otolaryngology-related terms were obtained from Google Trends. The means of relative search volume from the COVID-19 period (March 29, 2020 through May 16, 2020) were compared to similar periods from 2016 to 2019 using a t-test of two independent samples. RESULTS: In total, 16.6% of search terms had significant increases in relative search volume during the COVID-19 period, with the largest percentage increase for "can't smell" (124.4%, p = .006), followed by "allergies" (30.3%, p = .03), "voice pain" (26.1%, p = .008), and "ears ringing" (19.0%, p < .001). Of all search terms, 26.7% had significant decreases in relative search volume, including the largest percentage decrease for "laryngitis" (59.8%, p < .001), followed by "thyroid nodule" (54.4%, p < .001), "thyroid cancer" (45.6%, p < .001), and "ENT" (34.9%, p < .001). CONCLUSION: This study demonstrates that Google search activity for many otolaryngology-related terms during the COVID-19 pandemic has increased or decreased significantly as compared to previous years. With reduced access to in-office otolaryngology care in the United States during the COVID-19 pandemic, these are important considerations for otolaryngology practices to meet the needs of patients who lack access to care.

Surgical management and outcomes of accessory parotid gland neoplasms: A systematic review.

OBJECTIVE: To evaluate surgical approaches and outcomes associated with accessory parotid gland neoplasms. DATA SOURCES: MEDLINE, SCOPUS, and the Cochrane Central Register of Controlled Trials. REVIEW METHODS: A systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was performed. Studies were included if they reported surgical management and outcomes of patients with accessory parotid gland neoplasms. RESULTS: After screening 3532 records, 15 studies were included with a total of 187 patients. Benign tumors consisted of 61.5% of cases. External open, transoral, and preauricular endoscopic approaches were used for 82.3%, 11.3%, and 6.5% of cases, respectively. Accessory lobe resection alone, concurrent with partial parotidectomy, and concurrent with total parotidectomy were used in 54.8%, 43.0%, and 2.2% of cases, respectively. Complication rates were similar between histology groups (7.8% benign vs. 8.3% malignant, p = 0.82). Accessory lobe resection with concurrent partial parotidectomy had the lowest overall complication rate (6.3%). Resections limited to the accessory lobe were found to have an overall complication rate of 8.7%. CONCLUSION: The results offer an overview of the surgical management and complications for accessory parotid gland tumors. Overall surgical complication rates found in these case series may be lower for management of accessory gland tumors than rates available in the literature for tumors within the main parotid gland.

Local spikes in COVID-19 cases: Recommendations for maintaining otolaryngology clinic operations.

The Coronavirus Disease-2019 (COVID-19) pandemic has created an unprecedented economic and public health crisis in the United States. Following efforts to mitigate disease spread, with a significant decline in some regions, many states began reopening their economies. As social distancing guidelines were relaxed and businesses opened, local outbreaks of COVID-19 continue to place person on healthcare systems. Among medical specialties, otolaryngologists and their staff are among the highest at risk for becoming exposed to COVID-19. As otolaryngologists prepare to weather the storm of impending local surges in COVID-19 infections there are several practical measures that can be taken to mitigate the risk to ourselves and our staff.

Complications associated with energy-based devices during thyroidectomy from 2010-2020.

Objective: Harmonic Focus (Ethicon, Johnson and Johnson, Cincinnati, OH, USA), LigaSure Small Jaw (Medtronic, Covidien Products, Minneapolis, MN, USA), and Thunderbeat Open Fine Jaw (Olympus, Japan) are electrosurgical instruments used widely in head and neck surgery. The study aims to compare device malfunctions, adverse events to patients, operative injuries, and interventions related to Harmonic, LigaSure, and Thunderbeat use during thyroidectomy. Methods: The US Food and Drug Administration's Manufacture and User Facility Device Experience (MAUDE) database was queried for adverse events associated with Harmonic, LigaSure, and Thunderbeat from January 2005 to August 2020. Data were extracted from reports pertaining to thyroidectomy. Results: Of the 620 adverse events extracted, 394 (63.5%) involved Harmonic, 134 (21.6%) LigaSure, and 92 (14.8%) Thunderbeat. The reported device malfunctions most frequently associated with Harmonic was damage to the blade (110 (27.9%)), LigaSure was inappropriate function (47 (43.1%)), Thunderbeat was damage to the tissue or Teflon pad (27 (30.7%)), respectively. Burn injury and incomplete hemostasis were the most commonly reported adverse events. The operative injury reported most frequently when using Harmonic and LigaSure was burn injury. No operator injuries were reported with Thunderbeat use. Conclusion: The most frequently reported device malfunctions were damage to the blade, inappropriate function, and damage to the tissue or Teflon pad. The most frequently reported adverse events to patients was a burn injury and incomplete hemostasis. Interventions aimed at improving physician education may help reduce adverse events attributed to improper use.

Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020.

BACKGROUND: Till date, there have been no studies that have analyzed a database to examine postmarket adverse events associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. OBJECTIVE: To determine the postmarket complications associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. METHODS: The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was searched for adverse events associated with PROPEL bioabsorbable drug-eluting sinus stents between January 1, 2012 and December 31, 2020. Data were extracted and analyzed from medical device reports (MDRs) that involved sinus stents. RESULTS: After 47 MDRs were identified, 25 reports involving PROPEL bioabsorbable drug-eluting sinus stents were reviewed, from which 40 adverse events were recorded. Of these, there were 32 adverse events to patients and 8 device malfunctions. The most common adverse events to patients included infection (21.8%), oropharyngeal obstruction (15.6%), and headache/pain (12.5%). The most common device malfunction reported was migration and expulsion of the stent (87.5%). CONCLUSIONS: PROPEL sinus stents have been shown to be effective in preventing sinus outflow obstruction after functional endoscopic sinus surgery. Both adverse events to patients and device malfunctions are reported infrequently. A more comprehensive understanding of rare postmarket complications seen with PROPEL sinus stents may further aid informed decision-making regarding their usage.

I'm All Ears: A Population-Based Analysis of Consumer Product Foreign Bodies of the Ear.

OBJECTIVES: The purpose of this study was to assess the nationwide incidence of ear foreign body (FB) presentations to the emergency department (ED) and analyze the most common FB consumer products encountered. METHODS: The National Electronic Injury Surveillance System (NEISS) was evaluated for ED visits that included "ear foreign bodies" from 2010 through 2019. The most frequent foreign bodies were identified and organized by demographics. RESULTS: A total of 20,545 ear FB cases were found, with an estimated 608,860 ED visits nationwide. Female patients (56%) were more likely to have jewelry and first aid equipment FBs. Males between the ages of 5 and 15 years were significantly (P < 0.05) more likely to have paper products, pens/pencils, and desk supplies in their ears. CONCLUSION: Ear FBs represent a substantial proportion of healthcare expenditures. Although children are the most commonly affected individuals, all ages require further education and preventive measures.

Adverse Events Associated With Ossicular Prostheses: Utility of a Federal Database.

OBJECTIVES: Ossicular prostheses have demonstrated utility in ossicular chain reconstruction, but their use also is associated with complications. This study aims to explore the utility of the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database for the systematic analysis of complications associated with ossicular prostheses. It also summarizes adverse events to patients (AEPs) and device malfunctions (DMs) reported in the MAUDE database, and attempts to examine the consequences brought about by these events and to identify likely root causes. STUDY DESIGN: Retrospective analysis of the MAUDE database. METHODS: The MAUDE database was queried for reports from January 2010 to May 2020. Data were extracted from reports involving the use of ossicular prostheses. RESULTS: Seventy-three medical device reports, reports submitted to the Food and Drug Administration detailing suspected device-associated malfunctions, injuries, and deaths, involved ossicular prostheses and were included for analysis, from which 126 adverse events were extracted. Of these, 50 (39.7%) were AEPs, while 76 (60.3%) were DMs. The most common AEPs were foreign body and hearing loss, while the DMs reported most commonly were broken prosthesis and displaced prosthesis. Of the 76 DMs, 19 (25%) were attributed to mishandling by the operator, while 6 (7.9%) were due to a defective device. Broken prosthesis was the DM most commonly attributed to mishandling by the operator in 16 (32.7%) cases. CONCLUSION: Ossicular prostheses are used extensively for ossicular chain reconstruction, but also are associated with adverse events. The MAUDE database in its current form does not appear sufficient for the systematic review of adverse events associated with ossicular prostheses. A more standardized reporting format with clearly defined categories and inclusion of relevant variables might improve the quality of information provided by the MAUDE database.

Ultrasound-guided ethanol sclerotherapy for multifocal unilateral Warthin's tumor after partial parotidectomy.

Introduction: Warthin's tumor, also known as papillary cystadenoma lymphomatosum, is one of the most common benign salivary gland neoplasms. The current first-line treatment for Warthin's tumor is parotidectomy. However, surgical resection has the risk of complications including facial nerve weakness and Frey's syndrome. Recently, ultrasound-guided ethanol sclerotherapy (UGES) has been found to be efficacious in the treatment of a variety of head and neck lesions. Case report: We present a patient with multifocal Warthin's tumor who was managed with partial parotidectomy and two cycles of ultrasound-guided ethanol sclerotherapy. Discussion: Ethanol sclerotherapy has been used as a minimally invasive alternative to surgical excision or observation alone for a variety of head and neck masses. To our knowledge, this is the first case presented in the literature where sclerotherapy was used in conjunction with a partial parotidectomy. Minimizing the extent of surgical resection can reduce the risk of facial nerve weakness and Frey's syndrome and negate the need for fat grafting for defect reconstruction. Conclusion: UGES may serve as a safe and reliable procedure that can be performed in conjunction with partial parotidectomy for patients who wish to achieve definitive diagnosis while also minimizing the risk of complications associated with extensive parotidectomy.