MAUDE: Analysis of Robotic-Assisted Gynecologic Surgery

Abstract

Study ObjectiveTo evaluate the adverse events encountered during robotic gynecologic surgery, as reported to the FDA MAUDE database from January 2006 to December 2012. DesignDatabase search (Canadian Task Force classification III). InterventionA 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 ResultsTwenty-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. ConclusionIt 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.