Unreported robotic surgery injuries pose new FDA questions

More than 350,000 surgeries were performed with Intuitive Surgical Inc.’s robotic da Vinci device in 2012 alone. The use of robotic devices in surgery has expanded greatly in recent years. Unfortunately, however, injuries associated with these surgeries have also increased, and such injuries often lead to medical malpractice litigation.

Patients considering surgery may find it difficult to assess possible dangers. Gaps in reporting requirements mean that a clear, complete picture of injuries caused by robotic surgery devices is hard to find.

While the Food and Drug Administration maintains a list of reports of deaths and injuries sent by doctors and hospitals, the agency does not have the authority to compel doctors to make such reports. Hospitals are supposed to make the reports, but they often choose not to.

A Bloomberg News analysis of reports involving the da Vinci device found that dozens of patient injuries went unreported for years at a time. David Challoner, who co-authored a report by the Institute of Medicine calling for a better adverse event reporting system, said that the current system is a “disaster,” in part because medical professionals and medical device companies have an incentive to under-report patient problems.

The FDA said that it is aware of the problem of under-reporting and is working to improve the system.

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