Investigation Highlights Problems With Robotic Surgery

In recent years, robotic technology has become popular in operating rooms as a doctor’s aid during surgical operations. One of the most popular manufacturers of robotic medical devices is Intuitive Surgical Inc. The company’s da Vinci robotic surgery system, for example, was used in over 350,000 surgeries in 2012. Despite the adoption of these new systems, a recent investigation conducted by Bloomberg indicates that these robotic tools have caused serious injury for a large number of patients. In addition to the reported injuries, the survey showed that many robotic surgery injuries often go unreported.

Sheena Wilson, now on long-term disability and in need of a third corrective operation after a botched robot-assisted surgery, believes that doctors do not properly explain the risks and complications of robotic medical devices. Wilson says that if she had been aware of the injury risk, she would have never gone through with robot-assisted surgery.

Medical experts argue that the main reason so many injuries occur during surgeries performed with robotic medical tools is that doctors do not receive adequate training with these complex mechanisms. Enrico Benedetti, a surgeon working at a university hospital in Chicago, argues that in many cases, doctors begin using Intuitive Surgical’s tools after just a short training course and a few supervised operations with the devices. In many cases, Benedetti says, this brief training period explains why serious injuries like Sheena Wilson’s occur.

Benedetti’s feelings about lack of training are corroborated by doctors who have written about Intuitive Surgical Inc.’s tools on the company’s website. These medical professionals say that understanding how to use the company’s complex machines is their most pressing problem and go on to explain that these robotic tools have caused many injuries to patients during surgical procedures.
Perhaps even more troubling, though, is that when injuries are incurred via robotic surgery, physicians, surgeons, and doctors frequently fail to properly document and report these issues. In the medical field, the process of reporting this surgical trauma is referred to as “adverse event reporting.”

David Challoner, a Florida-based health professional, argues that the current reporting system in place is disastrously bad. The Food and Drug Administration also indicates that they know about the frequency of misreported or under-reported accidents, and are working diligently to revamp their reporting system.

The investigative report carried out by Bloomberg also suggests that injuries related to robotic medical tools go largely unreported. More specifically, after looking into an FDA report published in 2006, Bloomberg’s report indicates that only 15% of the estimated 1.1 million medical device injuries that occur annually are documented.

Source:

http://www.bloomberg.com/news/2013-12-30/unreported-robot-surgery-injuries-open-questions-for-fda.html