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 50,000 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.
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 50,000 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.
Authors: Orhan Agcaoglu; Shamil Aliyev; Halit Eren Taskin; Sricharan Chalikonda; Matthew Walsh; Meagan M Costedio; Matthew Kroh; Tomasz Rogula; Bipan Chand; Emre Gorgun; Allan Siperstein; Eren Berber Journal: Surg Endosc Date: 2012-06-08 Impact factor: 4.584
Authors: Blair A Wormer; Kristian T Dacey; Kristopher B Williams; Joel F Bradley; Amanda L Walters; Vedra A Augenstein; Dimitrios Stefanidis; B Todd Heniford Journal: Surg Endosc Date: 2013-11-07 Impact factor: 4.584
Authors: Amir Szold; Roberto Bergamaschi; Ivo Broeders; Jenny Dankelman; Antonello Forgione; Thomas Langø; Andreas Melzer; Yoav Mintz; Salvador Morales-Conde; Michael Rhodes; Richard Satava; Chung-Ngai Tang; Ramon Vilallonga Journal: Surg Endosc Date: 2014-11-08 Impact factor: 4.584
Authors: Emad Rajih; Côme Tholomier; Beatrice Cormier; Vanessa Samouëlian; Thomas Warkus; Moishe Liberman; Hugues Widmer; Jean-Baptiste Lattouf; Abdullah M Alenizi; Malek Meskawi; Roger Valdivieso; Pierre-Alain Hueber; Pierre I Karakewicz; Assaad El-Hakim; Kevin C Zorn Journal: Can Urol Assoc J Date: 2017-05-09 Impact factor: 1.862