Device failures associated with patient injuries during robot-assisted laparoscopic surgeries: a comprehensive review of FDA MAUDE database
Andonia Sero; Okeke Zeph; Okeke A. Deidre; Rastinehad Ardeshir; VanderBrink A. Brian; Richstone Lee; Lee R Benjamin;
Smith Institute for Urology, North Shore-Long Island Jewish Health System, New Hyde Park, New York, USA
INTRODUCTION: Robot-assisted laparoscopic surgery has increased in the areas of cardiac and urologic surgery. We sought to determine the number of reported device malfunctions leading to patient injuries.
METHODS: We performed a review of the MAUDE database of the FDA. Adverse events (AE) were defined as potential and actual product use errors and product quality problems. All incidents involving the ZEUS and da Vinci surgical robots were analyzed.
RESULTS: The MAUDE database was last accessed on August 27, 2007. A total of 189 AEs were reported from 2000 to August 27, 2007. Assuming that 50000 robotic-assisted laparoscopic cases have been performed, this represents 0.38% overall estimated failure rate. Twenty-one malfunctions were reported for the ZEUS robotic system between 2001 and 2003, while 168 malfunctions were reported for the da Vinci robotic system between 2000 and 2007. The rate of open conversions due to device malfunction decreased from 94% in 2003 to 16% in 2007. Of the 189 reported device malfunctions, only 9 (4.8%) were associated with patient injury.
CONCLUSIONS: The increasing use of robotic-assisted surgery has led to an increase in the number of reported device malfunctions, albeit at a very small estimated rate of 0.38%. With experience, the rate of open conversions due to device malfunction decreased. Only a small percentage of these adverse occurrences were associated with patient injury.