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

ABSTRACT

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.