Elmira Manoucheri1, Noga Fuchs-Weizman2, Sarah L Cohen2, Karen C Wang2, Jon Einarsson2. 1. Division of Minimally Invasive Gynecologic Surgery, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: emanoucheri@partners.org. 2. Division of Minimally Invasive Gynecologic Surgery, Brigham and Women's Hospital, Boston, Massachusetts.
Abstract
STUDY OBJECTIVE: To evaluate the adverse events encountered during robotic gynecologic surgery, as reported to the FDA MAUDE database from January 2006 to December 2012. DESIGN: Database search (Canadian Task Force classification III). INTERVENTION: A search of the FDA MAUDE database was performed by brand name "da Vinci" and manufacturer "Intuitive Surgical." Reports reflecting gynecologic procedures either by description or procedure name were included. A record of reports was kept to ensure that no duplicates were added. The date and type of event (operator-related error, technical system failure, or surgical injuries attributed to use of the robot) and the clinical outcome were recorded. MEASUREMENTS AND MAIN RESULTS: Twenty-six percent of reported events (n = 73) resulted in injury, and 8.5% (n = 24) resulted in death. Of note, although adnexal procedures were performed in <3% of the cohort, they accounted for 20% of the fatalities. Twenty-one percent of injuries were attributed to operator-related error, and 14% to technical system failure; 65% were not directly related to use of the robot. Fifteen deaths were reported during planned hysterectomy. Four of those were due to injury to a major blood vessel (iliac artery in 3, and aorta in 1), although a detailed description of how the injury occurred was absent from the event description. CONCLUSION: It is important to continue to evaluate the occurrence of injuries during robot-assisted surgery in an effort to identify unique challenges associated with this advanced technology. Published by Elsevier Inc.
STUDY OBJECTIVE: To evaluate the adverse events encountered during robotic gynecologic surgery, as reported to the FDA MAUDE database from January 2006 to December 2012. DESIGN: Database search (Canadian Task Force classification III). INTERVENTION: A search of the FDA MAUDE database was performed by brand name "da Vinci" and manufacturer "Intuitive Surgical." Reports reflecting gynecologic procedures either by description or procedure name were included. A record of reports was kept to ensure that no duplicates were added. The date and type of event (operator-related error, technical system failure, or surgical injuries attributed to use of the robot) and the clinical outcome were recorded. MEASUREMENTS AND MAIN RESULTS: Twenty-six percent of reported events (n = 73) resulted in injury, and 8.5% (n = 24) resulted in death. Of note, although adnexal procedures were performed in <3% of the cohort, they accounted for 20% of the fatalities. Twenty-one percent of injuries were attributed to operator-related error, and 14% to technical system failure; 65% were not directly related to use of the robot. Fifteen deaths were reported during planned hysterectomy. Four of those were due to injury to a major blood vessel (iliac artery in 3, and aorta in 1), although a detailed description of how the injury occurred was absent from the event description. CONCLUSION: It is important to continue to evaluate the occurrence of injuries during robot-assisted surgery in an effort to identify unique challenges associated with this advanced technology. Published by Elsevier Inc.
Authors: Maciej Nowacki; Łukasz Nazarewski; Tomasz Kloskowski; Dominik Tyloch; Marta Pokrywczyńska; Katarzyna Pietkun; Arkadiusz Jundziłł; Janusz Tyloch; Samy L Habib; Tomasz Drewa Journal: Arch Med Sci Date: 2016-08-25 Impact factor: 3.318