Ten-Year Food and Drug Administration Reporting on Robotic Complications in Gynecologic Surgery

Abstract

Objective: The United States Food and Drug Administration (FDA) Manufacture and User Device Experience (MAUDE) Database houses reports of deaths, injuries, and malfunctions related to FDA-approved devices. This article evaluates the 10-year statistics from MAUDE related to robotic gynecologic surgery. Materials and Methods: This study is a database analysis. The MAUDE database was queried for events occurring between 2003 and 2012. The following information was abstracted: date of surgery; report date; type of surgery; indication; injury sustained; interventions required; device malfunction; and involvement in legal proceedings. Results: During the 10 years studied, 455 injuries and 177 malfunctions were reported. Reporting increased over time. Gynecologic cases represented 61% of all reported robotic injuries; 81% of these led to legal proceedings. The most common gynecologic procedure resulting in injury was hysterectomy (n=399, 87%). Common complications included ureteral injuries (19%), infections (18%), and small-bowel injuries (16%). This resulted in 435 interventions, most commonly ureteral reimplantation (14%), bowel resection or repair (10%), and vaginal cuff closure (13%). Ninety-three device-related deaths were reported; 30 were associated with gynecologic surgeries. The most common cause of gynecologic procedure–related death was sepsis with or without bowel injury (28%) followed by hemorrhage (18%). Fifty adverse events resulted from 177 robot malfunctions. Conclusions: Reporting of robotic injuries, deaths, and malfunctions to the FDA is steadily increasing; however, as reporting in the MAUDE system is voluntary, the true incidence is unknown. Compulsory reporting would allow identification of absolute risks associated with robotic surgery and lead to improved root-cause analyses. (J GYNECOL SURG 31:331)