Operator error, system failure may equal injury In robotics

November 14, 2013

More than 30% of injuries during robotic surgery are related to operator error or robot failure but the majority of problems are not associated with the technology. So says a retrospective review of complications of robotic surgery reported to the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. The findings were presented at the 42nd AAGL Global Congress on Minimally Invasive Gynecology in Washington, DC.

 

More than 30% of injuries during robotic surgery are related to operator error or robot failure but the majority of problems are not associated with the technology. So says a retrospective review of complications of robotic surgery reported to the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. The findings were presented at the 42nd AAGL Global Congress on Minimally Invasive Gynecology in Washington, DC.

Researchers from Brigham and Women’s Hospital, Boston, MA, analyzed data on incidents with robotics reported from 2006 to 2012, during which the number of reports increased from 0 to 103 and the most common procedure was simple hysterectomy. Of the adverse events, 26% resulted in injury and 8.5% resulted in death. Of the 24 deaths reported, 11 were unrelated to use of the robot and the authors could not draw conclusions about what caused the remaining 13.

Operator error was responsible for 21% of injuries, 14% were caused by a technical system failure, and 65% were not directly related to use of the robot. The most common technical system failure was related to electrosurgery.  Four of the injuries related to operator error involved a surgeon activating uncontrolled instruments when he removed his hands from the patient site manipulator without removing his head from the console.

Because of under- reporting or selective reporting, the authors noted, the FDA MAUDE database may not fully reflect experience with the robotic system. They emphasized the need to continue evaluating occurrence of injuries during robot-assisted surgery to identify unique challenges associated with the technology.

Interviewed at the AAGL Congress, co-author Jon I. Einarsson, MD, PhD, MPH, emphasized that the results are "very limited by under-reporting" while also noting that the study was aimed at helping address concerns about the misperception that use of the robot can "create a better surgeon."

Fuchs WN, Cohen SL, Manoucheri E, et al. Surgical errors associated with robotic surgery in gynecology: A review of the FDA MAUDE database. Abstract 566. Presented November 12, 2013 at AAGL in Washington, DC.

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