Delayed Reporting of Robot Surgery Adverse Events

September 11, 2013 — The New York Times is warning that adverse events from robotic surgery may be under-reported, which could confound statistics indicating that robotic surgery is as safe as minimally-invasive laparoscopic surgery.

As an example, they cite the case of Erin Izumi, who suffered an injury after robot-assisted surgery for endometriosis in March 2009. Ten days after the 11-hour surgery, she was diagnosed with a torn colon and rectum that occurred during the procedure. She was hospitalized for five weeks and required a temporary colostomy.

Although hospitals are required to report adverse events to the FDA within 30 days, Ms. Izumi’s injuries were not reported until after she filed a lawsuit. Her claim was settled in May 2012.

A search of the FDA MAUDE adverse event database for robot surgery injuries reveals 276 adverse events (most of which did not involve patient injuries) and 23 deaths this year alone.

According to the Journal for Healthcare Quality, there were 174 injuries and 71 deaths associated with robotic surgery between January 2000 and August 2012. However, this number is alarmingly low considering that it has been used in over 1 million procedures.

The problem may be that doctors do not typically report complications involving user error. Researchers argue that these event should be reported because the rate of user error with the da Vinci Surgical Robot is higher than normal. Another problem is that many serious adverse events are only reported to the FDA after victims file lawsuits.

One adverse event, which occurred in 2002, was not reported to the FDA until February 2013, one month after it was reported by Citron Research.

Another adverse event was reported by the Wall Street Journal in May 2010, but not reported to the FDA until February 2013. The injury involved a 42-year old doctor named Carlos Chiriboga died after a robotic surgery. An attorney representing his family alleged that the urologist who operated on Dr. Chiriboga had never performed the surgery robotically before.