Patient injuries and malfunctions associated with robotic prostatectomy: review of the manufacturer and user facility device experience database

Abstract

Robotic prostatectomy is the most commonly performed robotic procedure in the United States. Increasing utilization of this procedure necessitates characterization of robot malfunctions and associated patient injuries. We performed a review of adverse events reported to a publicly available database. We searched the Manufacturer and User Facility Device Experience (MAUDE) database for reported adverse events (RAE) involving the intuitive surgical system. Reports involving prostatectomy from 2014 to 2019 were extracted and analyzed for data regarding death, patient injury, and device malfunction. Of 9109 reported adverse events (RAE), 602 were extracted for robotic prostatectomy over the study period. Seven were patient deaths (1.2%), 53 (8.8%) were patient injuries (Table 1), and 542 (90.0%) were malfunctions (Table 2). Malfunctions resulted in 25 aborted cases, 21 open conversions, and 25 laparoscopic conversions (71/542, 13.1%; Fig. 1). Instrument failures comprised the majority (76.4%) of malfunctions. Seven malfunctions (1.3%) resulted in patient injury. The most common device-related injury involved the monopolar curved scissors. No reported deaths were related to robot malfunction. Instrument failures comprise majority of the malfunctions of the Da Vinci robot during robot-assisted laparoscopic prostatectomy. When malfunctions do occur they are usually recoverable and rarely lead to patient injury.