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Delayed Reporting of Robot Surgery Adverse Events

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September 11, 2013 — Injuries associated with robotic surgery may be vastly under-reported, according to a new study and case report cited by the New York Times. This likely affects statistics indicating that robotic surgery and laparoscopic surgery have similar rates of adverse events.

The Times cited the case of Erin Izumi, who suffered a serious injury after a robotic surgery in 2009. Ten days after her 11-hour surgery, Ms. Izumi was diagnosed with a lacerated intestine. She was hospitalized for five weeks and required a series of medical procedures, including a colostomy.

Although hospitals are required to inform the FDA of adverse events within 30 days, the FDA only learned of Ms. Izumi’s injuries after she filed a lawsuit. She agreed to a settlement in May 2012.

A simple search of the MAUDE adverse event database reveals several examples of delayed reporting. For example, the Wall Street Journal reported the death of a 42 year-old doctor named Carlos Chiroboga in May 2010. Lawyers for Dr. Chiriboga’s family allege that it was the first time his doctor performed the surgery using a robot. The adverse event was not reported to the FDA until February 2013.

Another adverse event that occurred in 2002 was only reported to the FDA after it was published in Citron Research.

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