MAUDE: Analysis of Robotic-Assisted Gynecologic Surgery

Study Objective: To evaluate the adverse events encountered during robotic gynecologic surgery, as reported to the FDA MAUDE database from January 2006 to December2012. Design: Database search (Canadian Task Force classification III). Intervention: A search of the FDA MAUDE database was performed by brand name "da Vinci" and manufacturer "Intuitive Surgical." Reports reflecting gynecologic procedures either by description or procedure name were included. A record of reports was kept to ensure that no duplicates were added. The date and type of event (operator-related error, technical system failure, or surgical injuries attributed to use of the robot) and the clinical outcome were recorded. Measurements and Main Results: Twenty-six percent of reported events (n=73) resulted in injury, and 8.5% (n=24) resulted in death. Of note, although adnexal procedures were performed in <3% of the cohort, they accounted for 20% of the fatalities. Twenty-one percent of injuries were attributed to operator-related error, and 14% to technical system failure; 65% were not directly related to use of the robot. Fifteen deaths were reported during planned hysterectomy. Four of those were due to injury to a major blood vessel (iliac artery in 3, and aorta in 1), although a detailed description of how the injury occurred was absent from the event description. Conclusion: It is important to continue to evaluate the occurrence of injuries during robot-assisted surgery in an effort to identify unique challenges associated with this advanced technology.