Global robotic experience and the type of surgical system impact the types of robotic malfunctions and their clinical consequences: An FDA MAUDE review

摘要

This paper addresses a very important issue that has been minimally addressed in recent literature. The authors assess da Vinci Surgical System malfunctions using the FDA MAUDE database, a voluntary publicly available data system. The authors did find some differences between the first generation (dV) and second generation (dVS) systems with respect to malfunction and open conversion rates; however, overall malfunctions and conversions declined over time.There are inherent limitations to a voluntary reporting of malfunction rates, resulting in a significant under-representation of events. Overall, the unrecoverable fault rate with the technology is low; however, we need to continue to critically evaluate this outcome as we become more reliant on the technology in our operation rooms. Patients are directly asking this exact question, and what the next steps would be if the robot malfunctions.