A novel surgical technique for removal of intramedullary nails when there is a failure of the proximal extraction device: Report of two cases and review of literature.

Diaphyseal fractures of the tibia is a common injury with an incidence of 16.9/100,000 population. Surgical treatment with intramedullary interlocking nail is the treatment of choice in closed diaphyseal tibial injuries. Removal of the nail is required in non-union, infected implant, implant failure or during exchange nailing procedure. Implant removal surgery presents some unique challenges to the Orthopaedic surgeons like broken nails, broken screws and failure of the extraction devices to engage with the threads of the nail due to stripping of the threads in the proximal part of the nail. Various techniques have been described by different authors to extract a broken distal piece of the nail. There are only a few articles described for the removal of an intramedullary nail when there is failure of the proximal extraction device. The failure of the proximal extraction device occurs due to the use of ill-fitting extraction bolts, cross threading and the presence of a very tight nail leading to stripping of the proximal threads. We describe a simple and novel technique with the use of the Stainless-Steel wire along with the extraction bolt when there is a failure of proximal extraction device for the extraction of cannulated or solid intramedullary nails.

Implantable cardioverter-defibrillator lead failure and revision following transcutaneous bicaval valve (TricValve®) implantation.

INTRODUCTION: Tricuspid regurgitation is associated with significant morbidity and mortality, and occurs at a higher rate in patients with cardiovascular implantable electronic devices. Percutaneous strategies for managing tricuspid regurgitation are evolving, including the development of bicaval valve implantation which has been successfully used in patients with pacing leads. METHODS AND RESULTS: We present the first documented case of lead failure following TricValve® implantation, a dedicated self-expanding system for bicaval valve implantation, and the first successful lead revision procedure in this setting. CONCLUSION: The case illustrates important considerations in undertaking percutaneous intervention in patients with cardiovascular implantable electronic devices, and their ongoing management.

Postconception age at surgery as a predictor of ventriculoperitoneal shunt failure.

OBJECTIVE: The gold standard of pediatric hydrocephalus management is the ventriculoperitoneal (VP) shunt. However, VP shunts have high failure rates, and both young age and prematurity have been identified as potential risk factors for shunt failure, although neither variable describes total development at the time of surgery. This study aimed to further characterize age and shunt failure through the use of postconception age at surgery (PCAS) as well as investigate the 40-week PCAS threshold initially described in 1999. METHODS: A retrospective analysis was conducted on all first-time shunt placements at the authors' institution from 2010 to 2021. The National Surgical Quality Improvement Program (NSQIP) pediatric hydrocephalus dataset was used as a parallel analysis to ensure representativeness of the national pediatric hydrocephalus population. RESULTS: In the institutional cohort, infants with a PCAS < 40 weeks exhibited 2.4 times greater odds of shunt failure than those with a PCAS ≥ 40 weeks. In the NSQIP dataset, infants with a PCAS < 40 weeks had 1.45 times greater odds of shunt failure compared with those with a PCAS ≥ 40 weeks. CONCLUSIONS: The 40-week PCAS threshold appears to be a significant predictor of shunt failure in pediatric patients with hydrocephalus. This finding underscores the importance of considering the developmental stage at the time of surgery, rather than just prematurity status, when assessing shunt failure risk.

Adverse events of the single-operator cholangioscopy system: a Manufacturer and User Facility Device Experience database analysis.

BACKGROUND AND AIMS: The SpyGlass (Boston Scientific, Marlborough, Mass, USA) single-operator cholangioscopy (SOC) system is generally considered to be safe but adds additional risks to those associated with standard ERCP. METHODS: We evaluated adverse events (AEs) associated with the SpyGlass system reported in the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database between January 2016 and August 2023. RESULTS: From the database, 2311 device problems (SpyGlass DS, 1301; SpyGlass DS II, 1010) were reported. An optical problem was the most reported issue (SpyGlass DS, 83; SpyGlass DS II, 457). Patient-related events were found in 62 of 1743 reports (3.5%): 33 with the SpyGlass DS and 29 with the SpyGlass DS II. The most common AEs were bleeding/hemorrhage followed by perforation; infection, fever, or sepsis; and pancreatitis. CONCLUSIONS: Our findings add to the existing literature and provide a fuller picture of potential problems associated with the SpyGlass SOC.

Impact of Angle of File Access and Location of Canal Curvature on the Dynamic Cyclic Fatigue of Nickel Titanium Rotary Instruments.

OBJECTIVE: To evaluate the impact of different file access angles and root canal curvature's location on the fatigue failure of One Curve (OC) and E3 Azure (EZ) NiTi files using a dynamic model at simulated body temperature. METHODS: Eighty new instruments with similar tip sizes and taper (#25/0.06) from two NiTi rotary systems, One Curve and E3 Azure, were tested at simulated body temperatures (37°C) using a custom-made dynamic cyclic fatigue device. Instruments were divided into four subgroups according to the location of root canal curvature (a coronal curve 5 mm from the root canal orifice and an apical curve 10 mm from the root canal orifice) and the angle of file access (0° or 30°). Instruments were operated in simulated stainless-steel canals having a 60° curve and a 3 mm radius. A custom-made device produced controlled vertical pecks during file rotation. Time to failure (sec) was registered, and the length of the fragment segments was measured (mm). Data were analysed statistically with One-Way ANOVA and Tukey post hoc tests. The significance level was set at 5%. All separated instruments were examined by scanning electron microscope. RESULTS: One-way ANOVA (p<0.05) found a significant difference among the tested instruments. Post Hoc analysis revealed lower cyclic fatigue resistance when the angle of file access was 30º, and the root canal curvature was located coronally for both files (p<0.0001). Three-way ANOVA showed that the angle of file access was the most influential contributor to cyclic fatigue, followed by the location of file curvature and, finally, the file type (p<0.0001). The fractographic examination revealed a predominantly ductile fracture mode for all tested instruments. The lengths of all fractured segments showed no significant difference (p>0.05), indicating an accurate trajectory during testing. CONCLUSION: OC files had superior cyclic fatigue resistance than EZ files; coronal curvatures negatively impacted cyclic fatigue resistance compared to apical curvatures, while the angle of file access presented the highest impact on dynamic cyclic fatigue.

The Knotted Urethral Catheter-Description of a Novel Technique and Steps for Removal.

ABSTRACT: The spontaneous intravesicular knotting of a feeding tube used for urethral catheterization is a rare but documented complication. The reported incidence in the world literature is 0.2 per 100,000, with only 40 cases reported. Removal of these intravesicular knots has been attempted in a number of ways, such as the use of a guide wire to untangle the knot, use of excess lubrication and traction with or without anesthetic, and percutaneous or open cystostomy. This cystoscopic technique for removal has not been previously described.Based on our experience and published recommendations, we formulate an algorithm for removal. We outline steps for prevention and techniques from simple to complex, which can be used to remove knotted catheters.Although a rare complication of catheterization in children, catheter knotting can be troublesome. Following the steps suggested in this algorithm may avoid the use of more invasive techniques for removal.

The role of stiffness-matching in avoiding stress shielding-induced bone loss and stress concentration-induced skeletal reconstruction device failure.

It is well documented that overly stiff skeletal replacement and fixation devices may fail and require revision surgery. Recent attempts to better support healing and sustain healed bone have looked at stiffness-matching of these devices to the desired role of limiting the stress on fractured or engrafted bone to compressive loads and, after the reconstructed bone has healed, to ensure that reconstructive medical devices (implants) interrupt the normal loading pattern as little as possible. The mechanical performance of these devices can be optimized by adjusting their location, integration/fastening, material(s), geometry (external and internal), and surface properties. This review highlights recent research that focuses on the optimal design of skeletal reconstruction devices to perform during and after healing as the mechanical regime changes. Previous studies have considered auxetic materials, homogeneous or gradient (i.e., adaptive) porosity, surface modification to enhance device/bone integration, and choosing the device's attachment location to ensure good osseointegration and resilient load transduction. By combining some or all of these factors, device designers work hard to avoid problems brought about by unsustainable stress shielding or stress concentrations as a means of creating sustainable stress-strain relationships that best repair and sustain a surgically reconstructed skeletal site. STATEMENT OF SIGNIFICANCE: Although standard-of-care skeletal reconstruction devices will usually allow normal healing and improved comfort for the patient during normal activities, there may be significant disadvantages during long-term use. Stress shielding and stress concentration are amongst the most common causes of failure of a metallic device. This review highlights recent developments in devices for skeletal reconstruction that match the stiffness, while not interrupting the normal loading pattern of a healthy bone, and help to combat stress shielding and stress concentration. This review summarises various approaches to achieve stiffness-matching: application of materials with modulus close to that of the bone; adaptation of geometry with pre-defined mechanical properties; and/or surface modification that ensures good integration and proper load transfer to the bone.

Analysis of Determinants for Suture-mediated Closure Device Failure During EVAR Procedures.

OBJECTIVE: Endovascular aortic repair (EVAR) for elective and emergency infrarenal aortic pathologies is the primary approach for treatment nowadays. During such procedure, the suture-mediated closure device (SMCD) (Perclose ProGlideTM, Abbott Laboratories, Chicago, IL, USA) is commonly used. This study aimed to identify potential contributors for SMCD failure in a patient cohort of elective and emergency EVAR. METHODS: Archived medical records from patients who underwent EVAR for aortic pathologies in elective and emergency setting at the University Hospital Düsseldorf, Germany were included. Patient's co-morbidities, access vessel morphologies and hemostasis-related blood parameters were evaluated on their association with SMCD failure applying different statistical methods. RESULTS: A total of 71 patients (139 femoral accesses) was included. The mean age was 73.5 ± 8.4 years. Overall SMCD failure rate was 4.3%, 4.1% for elective and 5.9% for emergency cases, respectively. Total procedure time was longer for the SMCD failure group (323 ± 117.8 min vs 171 ± 43.7 min). The calcification status of the common femoral artery (CFA), the diameter of the aortic bifurcation, and dual anti-platelet therapy (DAPT) on the medication plan prior to the procedure were associated with SMCD failure. Univariate binary logistic regression analysis nominated several potentially relevant predictors for SMCD failure who underwent subsequent multivariable binary logistic regression analysis. Here, DAPT on the medication plan was identified as being promising in predicting SMCD failure (OR 30.5), while anterior plaque formation in the CFA maintained as only statistically relevant determinant (OR 44.9). CONCLUSIONS: This study confirms the CFA calcification status to be associated with SMCD failure. Although discontinued prior to endovascular treatment, DAPT was also found to be associated with SMCD failure. Our results may advocate to perform obligatory platelet testing prior to EVAR to maximize patient safety.

Upper airway stimulation device failure: A 7-year single center experience.

OBJECTIVE: To identify and report a single center experience with upper airway stimulator device-related failures. STUDY DESIGN: Retrospective case series. SETTING: Single tertiary academic center. METHODS: Retrospective data on 352 patients who underwent UAS surgery with an Inspire device from 2016 to 2023 was collected, including demographics, comorbidities, and nature of device failure requiring revision surgery. RESULTS: Out of the 348 patients included in our analysis, 16 (4.6 %) required revision due to device failure, with an average interval of 772 days (∼2 years) between initial implant and revision. Most failures were attributed to respiratory sensing lead damage (n = 11, 68.8 %), resulting in high system impedance and subsequent device malfunction. Lead fracture causes varied, including idiopathic occurrences and potential trauma. Lead migration was noted in one case (6.3 %), where the hypoglossal electrode detached from the nerve. Two patients (12.3 %) required implantable pulse generator (IPG) replacement, one after experiencing trauma and the other due to unclear source of malfunction. One patient (6.3 %) required complete system replacement following high lead impedance and absent tongue motion. The last patient required replacement of both the IPG and respiratory lead after experiencing high lead impedance (6.3 %). CONCLUSION: Respiratory sensing lead fracture emerged as the leading cause of device failure in this cohort, underscoring the need to address this under-reported issue, potentially linked to the time lapse after device implantation.

Phase transformation and mechanical properties of heat-treated nickel-titanium rotary endodontic instruments at room and body temperatures.

BACKGROUND: The aim of this study was to evaluate the phase composition, phase transformation temperatures, bending property, and cyclic fatigue resistance of different heat-treated nickel-titanium (NiTi) rotary instruments with the same tip diameter and taper at room (RT; 25 ± 1 °C) and body (BT; 37 ± 1 °C) temperatures. METHODS: Five heat-treated NiTi rotary instruments, HyFlex EDM (EDM), HyFlex CM (CM), Vortex Blue (VB), RE file CT (RE) and JIZAI, and a non-heat-treated NiTi rotary instrument (Mtwo) with a size 40, 0.04 taper were investigated. Temperature-dependent phase transformation was examined with differential scanning calorimetry (DSC). The bending loads of the instruments at RT and BT were evaluated using a cantilever-bending test. Cyclic fatigue resistance at RT and BT was measured using a dynamic test, during which the instruments were rotated in combination with a 2-mm back-and-forth motion in an artificial curved canal, and the number of cycles to failure (NCF) was determined. The results were analyzed using two-way repeated measures analysis of variance, a simple main effect test, and the Bonferroni test (α = 0.05). RESULTS: DSC results indicated that EDM and Mtwo were primarily composed of martensite/R-phase and austenite, respectively, while the other heat-treated instruments were composed of a mix of martensite/R-phase and austenite at the tested temperatures. Regardless of the temperature setting, the bending loads of heat-treated instruments were significantly lower than those of Mtwo (p < 0.05). EDM showed the lowest bending loads and highest NCF at both temperatures (p < 0.05). CM, VB, and JIZAI showed significantly higher bending loads at BT than at RT (p < 0.05). The NCF of all the heat-treated instruments, except VB, was lower at BT than at RT (p < 0.05). At BT, the NCF of CM, VB, RE, and JIZAI were not significantly higher than that of Mtwo (p > 0.05). CONCLUSIONS: Heat-treated NiTi instruments exhibited lower bending loads and higher NCF values than Mtwo. However, this tendency was less pronounced at BT than at RT, especially in the NCF values of instruments with a mixture of martensite/R-phase and austenite phases at the tested temperatures.

Influence of sodium hypochlorite on cyclic fatigue resistance of nickel-titanium instruments: A systematic review and meta-analysis of in vitro studies.

OBJECTIVE: This systematic review/meta-analysis investigated the influence of NaOCl on cyclic fatigue resistance of endodontic NiTi instruments. MATERIALS AND METHODS: A systematic search until July 2022 in PubMed/MEDLINE, Embase, Scopus, Web of Science, SciELO, Cochrane Library, and grey literature was conducted. According to the PECOS strategy, only in vitro studies evaluating the effects of NaOCl on the cyclic fatigue resistance of NiTi instruments were eligible. Cyclic fatigue resistance was the primary outcome. A modified Joanna Briggs Institute's Checklist was used for risk of bias assessment. RESULTS: Of the 2,445 records screened, 37 studies were included. Most studies used simulated canals made of stainless-steel block with severe to moderate curvatures. NaOCl concentration varied from 1-6%, mainly at 37 °C. Regarding fatigue resistance, 23 studies using 1.2% to 6% NaOCl showed a reduction in the resistance compared to the control groups, especially when pre-heated. Four meta-analyses were performed according to the tested NiTi systems. The meta-analyses indicated that the PTU F2 files had higher reduction of fatigue resistance after exposure to 5.25% NaOCl; no differences between NaOCl and no immersion were observed for Reciproc R25, WaveOne 25.08, and WaveOne Gold Primary files. Included studies had low risk of bias. CONCLUSION: NaOCl appears to reduce cyclic fatigue resistance of certain NiTi files, especially when they are pre-heated, particularly in conventional NiTi files compared to some heat-treated instruments. It is possible that the temperature of the solution may have a greater influence on resistance than NaOCl itself. Important to note that an overall tendency toward no significant influence was observed among various systems. CLINICAL RELEVANCE: Precautions are necessary when a pre-heated high-concentration NaOCl is used to enhance its properties during root canal preparation, mainly using conventional wire.

Cyclic fatigue resistance of different nickel-titanium instruments in single and double curvature at room and body temperatures: A laboratory study.

The aim of this study was to compare the cyclic fatigue resistance of nickel-titanium instruments inside single and double-curved canals at different temperatures. 160 HyFlex EDM #20.05 (HEDM), VDW.ROTATE #20.05 and #25.06, Mtwo #25.06 were randomised (n = 10) for the dynamic cyclic fatigue tests according to the curvature (i.e. single and double) at 20° ± 1°C and 35° ± 1°C. The number of cycles to fracture (NCF) was analysed by two-way ANOVA with p < 0.05. Fatigue resistance of all instruments significantly decreased at body temperature in single and double curvatures, except for HEDM in double curvature. The NCF was significantly lower in double curvature than single at both temperatures for all files, except for VDW.ROTATE #20.05 at 35° ± 1°C. Within the study limitations, temperature significantly impaired cyclic fatigue resistance of all files except HEDM #20.05 in double curvature. Similarly, double curvature had a detrimental effect on cyclic fatigue resistance of all files except for VDW.ROTATE #20.05 at body temperature.

Bypass de instrumento endodôntico fraturado: relato de caso / Bypass of a fractured endodontic instrument: case report

Introdução: Mesmo com toda evolução tecnológica desses instrumentos, com o desenvolvimento das limas de liga de níquel-titanio (NiTi) e sistemas mecanizados, as fraturas podem ocorrer durante o preparo químico/mecânico. Existem três abordagens mais regulamente aplicadas para solucionar essa intercorrencia: tentativa de remoção do instrumento com ultrassom, tentativa de ultrapassálo (bypass) ou a obturação do segmento. Objetivo: Relatar um caso da técnica de bypass em instrumento fraturado no canal radicular. Descrição do caso: Paciente, sexo feminino, 47 anos, brasileira, sem condições sistêmicas associadas, foi encaminhada à clínica do Curso de Odontologia da UNIFENAS, Divinópolis, Minas Gerais, Brasil, para resolução de fratura de instrumento no canal mésio- vestibular do primeiro molar superior direito (16). Optou-se pelo tratamento pela técnica de bypass, que envolveu as seguintes etapas: anestesia, abertura, utilização de lima C-Pilot #08 para ultrapassar o instrumento fraturado, odontometria, escalonamento regressivo a partir da lima k#20, desinfecção com hipoclorito de sódio 5%, medicação com hidróxido de cálcio por 21 dias, agitação da substância irrigadora e obturação dos canais radiculares. Conclusão: O bypass ao instrumento é uma técnica conservadora, eficaz e uma solução adequada em casos de fratura de limas endodônticas dentro dos canais radiculares. Essa técnica visa preservar o máximo possível da estrutura dental original, evitando procedimentos mais invasivos.(AU)

Introduction: Even with all technological evolution of these instruments, with the development of nickel-titanium alloy (NiTi) files and mechanized systems, fractures can occur during chemical/mechanical preparation. There are three most commonly applie to resolve this complication: attempting to remove the instrument with ultrasound, attempting to bypass it, or obturating the segment. Objective: To report a case of bypass technique in fractured instrument in the root canal. Case description: A 47-year-old female patient from Brazil, with no associated systemic conditions, was referred to the clinic of the Dentistry Course at UNIFENAS, Divinópolis, Minas Gerais, Brazil, for resolution of an instrument fracture in the mesio-vestibular canal of the right upper first molar (16). Treatment was performed using the bypass technique, which involved the following steps: anesthesia, opening, use of a C-Pilot #08 file to bypass the fractured instrument, odontometry, regressive scaling from the k#20 file, disinfection with 5% sodium hypochlorite, medication with calcium hydroxide for 21 days, agitation of the irrigating substance and root canal filling. Conclusion: Instrument bypass is a conservative, effective technique and an adequate solution in cases of endodontic file fracture within root canals. This technique aims to preserve as much of the original tooth structure as possible, avoiding more invasive procedures.(AU)

The experience of device failure after cochlear implantation.

BACKGROUND: The present study describes the treatment of patients at a tertiary institution who experienced device failure after Cochlear Implantation (CI), as well as identifying prodromic symptoms that could assist in the timely identification and management of device failure. STUDY DESIGN: Retrospective database review (January 2000-May 2017). SETTING: Single tertiary hospital. METHODS: Factors recorded included the etiology of hearing loss; age at first and revision CI surgeries; surgical information, including operation time and approach; electrical outcomes after implantation; device implanted; symptoms of device failure; history of head trauma; and audiologic outcomes as determined by categories of auditory performance (CAP). RESULTS: From January 2000 to May 2017, 1431 CIs were performed, with 27 (1.9%) undergoing revision surgeries due to device failure. The most common etiology of hearing loss was idiopathic (12/27), followed by cochlear hypoplasia (5/27). Mean age at initial CI was 11.8 (1-72) years, with 21 being pre-lingual and 6 being post-lingual. Of the total devices initially implanted, 80.5% were from Cochlear, 15.9% from MED-EL, and 3.5% from Advanced Bionics. The failure rates of these devices were 1.3%, 3.1%, and 10.0%, respectively. The most suggestive symptom of device failure was intermittent loss of signal. Mean CAP scores were 5.17 before reimplantation and 5.54 and 5.81 at 1- and 3-years, respectively, after reimplantation. CONCLUSION: The most suggestive symptom preceding device failure was intermittent loss of signal. Patients who present with this symptom should undergo electrical examination for suspected device failure. Audiologic outcomes showed continuous development despite revision surgeries.

Augmented Reality-Supported Rod Bending in Multilevel Spinal Fusion Using the ADVISE Software.

BACKGROUND: One of the most common reasons for poor patient outcomes and revision surgery in spinal fusion is hardware failure. Screw loosening or pullout occurs in up to one-quarter of all cases. It is known that even small screw-rod misalignments can cause significant mechanical overloads during rod fixation, which can result in hardware failure. To address this crucial surgical step, a novel augmented reality-assisted software was developed to generate custom rod templates that are precisely adapted to the individual patient. METHODS: The novel software, which runs on a tablet, is used in spinal fusion surgery and is based on the use of a specific pedicle screw system, in which the polyaxial screw heads are connected to detachable guides. These guides can be recognized by the tablet camera and a light detection and ranging scanner. This image information is processed to determine the spatial positions of the screw heads and to calculate an ideally fitting rod template. RESULTS: The calculated rod template is displayed in a 1-to-1 scale on the tablet screen. This template is used to cut and bend the rods of the pedicle screw system. Finally, the custom bent rod can be inserted into the screw heads without tension. CONCLUSIONS: The augmented reality-assisted software is intended to give surgeons access to patient-specific intraoperative real-time data, helping them in bending rods that are more precisely adapted to the individual patient compared with the freehand technique.

A critical evaluation of physical and manufacturing properties of genuine and counterfeit rotary nickel-titanium endodontic instruments.

BACKGROUND: Rotary nickel-titanium (NiTi) instruments are made to exacting standards and are costly to manufacture, and quality control is paramount. Consequently, unauthorized factories make counterfeit instruments that are less expensive and may therefore be attractive to dentists. Little information exists about the metallurgy and manufacturing quality of such instruments. There is the potential for counterfeit instruments to be at higher risk of fracture during treatment, thereby compromising clinical outcomes. The aim of this study was to evaluate physical and manufacturing properties of genuine and counterfeit ProTaper Next™ and Mtwo® rotary NiTi instruments. METHODS: This study investigated the metallurgical properties, manufacturing quality, microhardness and number of cycles to failure of two commonly used rotary NiTi systems and compared them with counterfeit products purporting to be genuine articles. RESULTS: Counterfeit instruments were found to be inferior in manufacturing standards and were less resistant to cyclic fatigue when compared to genuine instruments. CONCLUSIONS: Counterfeit rotary NiTi instruments may be less efficient at preparing root canals and may be at higher risk of fracture during endodontic treatment. Dentists must be aware that, although less expensive, counterfeit instruments may be of dubious manufacturing quality and at higher risk of fracture if used in patients. © 2023 Australian Dental Association.

Dynamic Cyclic Fatigue Resistance of Heat-treated Nickel Titanium Instruments in Reciprocating Motion.

OBJECTIVE: To compare the fatigue resistance of different heat-treated reciprocating instruments tested in a dynamic cyclic fatigue model. METHODS: Forty-eight new instruments were inspected under magnification and selected for this study, and then divided as follows (n=12): X1 Blue (MK Life, Porto Alegre, RS, Brazil), Pro-R (MK Life), Reciproc (VDW, Munich, Germany), and Reciproc Blue (VDW). Artificial canals presenting a curvature of 60° angle and 5 mm radius were milled in zirconia. The block containing the artificial canals was mounted in a container filled with water kept at 37°C. A specially designed device was used to perform controlled axial movements while the instruments were activated inside the canals. Time to failure was recorded in seconds, and fragment lengths were measured (mm). Data were analyzed statistically with the significance level set at 5% (One-Way ANOVA and Tukey test). RESULTS: Pro-R and Reciproc Blue instruments presented the highest fatigue resistance, being significantly different from the other tested files (p<0.05). Reciproc presented intermediate results, significantly different X1 Blue (p<0.05). The fractographic analysis showed typical features of cyclic fatigue for all instruments. CONCLUSION: Pro-R and Reciproc Blue instruments are more resistant to dynamic cyclic fatigue than the Reciproc and X1 Blue. (EEJ-2022-10-124).

Device Failure and Adverse Events Related to Single-use and Reusable Flexible Ureteroscopes: Findings and New Insights From an 11-Year Analysis of the Manufacturer and User Facility Device Experience Database.

OBJECTIVE: To catalog and characterize device failures and adverse events related to flexible ureteroscopes from a national database. METHODS: Search of the Manufacturer User and Facility Device Experience database was performed for all recorded events related to flexible ureteroscopes between 2012 and 2022. The following information was collected: Problem and cause, timing, complications and injury, prolonged anesthesia, and early termination of procedure. Event severity was graded using a validated tool. RESULTS: A total of 206 events were identified (reusable/single use ratio, 2.5:1). There were 20 different problem categories reported, which included image loss (26.7%), difficulty removing scope (13.6%), scope damage from basket (4.4%), detachment of scope tip (5.8%) and contamination (4.9%). Faulty device was the predominant cause for an event related to single-use scopes (86.4%); this was seldom the case for reusable (2%). Patient injury occurred in 21.8%, but these were all in reusable scopes. No deaths were reported, but major complications included complete avulsion of the ureter (3.4%) and fully entrapped scope necessitating open surgery (2.9%). While the safety profile for single-use scopes was superior, they were significantly more likely to result in early termination (71.1% vs 37.3%, P < .001). This was related to 76.3% of the single-use scopes experiencing sudden image loss. CONCLUSION: Flexible ureteroscopes are fragile, and a multitude of problems can occur. Many of these can be avoided through correct surgeon technique and robust maintenance services.