Malfunction Events in the US FDA MAUDE Database: How Does Robotic Gynecologic Surgery Compare with Other Specialties?

STUDY OBJECTIVE: To review malfunction events (MEs) related to the use of the da Vinci robot reported to the United States Food and Drug Administration Manufacturer and User Facility Device Experience in the last 10 years and compare gynecologic surgery with other surgical specialties. DESIGN: A retrospective review. SETTING: Manufacturer and User Facility Device Experience database. PATIENTS: Reports from 2010 to 2020 with keywords "Davinci" and "Intuitive". INTERVENTIONS: Report review. MEASUREMENTS AND MAIN RESULTS: There were 679 reports included in the final analysis. Most MEs occurred intraoperatively (81.7%) and were related to robotic instrument malfunction (84.5%), and 30% required an instrument switch to complete the procedure. Conversion to open and laparoscopic surgery was required in 3.1% and 1.3% of MEs, respectively. Injury to the patient occurred in 15.6% of MEs. Of the reported injuries to patients, 6.6% were related to robotic malfunction, 49.2% to instrument malfunction, and 18% to surgeon or staff misuse of the robotic system, and 15.6% were complications inherent to the procedure, not related to the robotic system. Of all the reported MEs, 4.4% were related to robot malfunction, 1.5% to console malfunction, 73.3% to Intuitive accessory malfunction, 11.2% to other accessory malfunction, 4% to surgeon or staff misuse of robotic system, and 3% to complications inherent to the procedure. Comparison between gynecologic surgery and other surgical specialties showed that 14.4% of issues were solved intraoperatively in gynecologic surgery vs 13.7% in other specialties (p = .185). The procedure was completed robotically in 85.2% in gynecologic surgery vs 84% in other specialties, laparoscopically 4.6% vs 3.7%, and open in 10.2% vs 12.4%, respectively (p = .883). In gynecologic surgery, reported MEs were made by patients in 14.8% vs 4.8% in other specialties, manufacturer in 78.4% vs 74.2%, and operating room staff in 2.3% vs 16.1%, respectively (p = .007). Injury to patient was similar in gynecologic surgery compared with other specialties (35.1% vs 23.4%, p = .122). Gynecologic and other specialty MEs did not state the need for procedure rescheduling (0% vs 0%). CONCLUSION: Most reported robotic MEs occurred intraoperatively, were related to robotic instrument malfunctions, and required an instrument switch. Most surgeries are completed robotically, but conversion to either an open or laparoscopic approach was reported in 4.4%. Of the 114 reported injuries, 47.4% were Clavien-Dindo grade III+. There were no differences noted in patient injury between gynecologic surgery and other specialties.

Compliance With Surgical Oncology Specialty Care at a Safety Net Facility.

BACKGROUND: Social determinants of health challenge in at-risk patients seen in safety net facilities. STUDY DESIGN: We performed a retrospective review of surgical oncology specialty clinic referrals at a safety net institution evaluating referral compliance and times to first appointment and initiation of definitive treatment. Main outcomes measured included completion of initial visit, initiation of definitive treatment, time from referral to first appointment, and time from first appointment to initiation of definitive treatment. RESULTS: Of 189 new referrals, English was not spoken by 52.4% and 69.4% were Hispanic. Patients presented without insurance in 39.2% of cases. Electronic patient portal was accessed by 31.6% of patients. Of all new referrals, 55.0% arrived for initial consultation and 53.4% initiated definitive treatment. Malignant diagnosis (P < .0001) and lack of insurance (P = .01) were associated with completing initial consultation. Initiation of definitive treatment was associated with not speaking English (P = .03), malignant diagnosis (P < .0001), and lack of insurance (P = .03). Times to first appointment and initiation of definitive treatment were not significantly affected by race/ethnicity, language, insurance, treatment recommended, or electronic patient portal access. CONCLUSION: Access to surgical oncology care for at-risk patients at a safety net facility is not adversely affected by lack of insurance, primary spoken language, or race/ethnicity. However, a significant proportion of all patients fail to complete the initial consultation and definitive treatment. Lessons learned from safety net facilities may help to inform disparities in health care found elsewhere.

Investigation of a Peculiar Case of Childhood Lymphadenopathy.

Introduction: Lymphadenopathy is a common physical finding often associated with an infectious etiology. We present a case of a patient with generalized cervical and supraclavicular lymphadenopathy diagnosed with a rare malignancy. Health care providers should be aware of some uncommon historical or physical examination findings that warrant further investigation. Clinical Findings: A 16-year-old female presented to the emergency department with 3 days of a fever, congestion and sore throat with swelling around the jaw. Her physical examination findings included bilateral mandibular swelling and generalized cervical lymphadenopathy with palpable supraclavicular lymph nodes. Outcomes: Complete blood count showed pancytopenia with a white blood cell count of 4.4 × 10e3/uL, hemoglobin of 10.8 g/dL and platelets of 87 × 10e3/uL. CT scan of the neck with IV contrast revealed extensive cervical and mediastinal lymphadenopathy with suspicion of lymphoma. Biopsy results diagnosed a rare form of a hematologic malignancy called blastic plasmacytoid dendritic cell neoplasm. Conclusions: The presence of supraclavicular lymphadenopathy should raise concern for non-infectious etiologies, such as malignant processes.