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Robotic surgery injuries under-reported

Patients in Chicago, Illinois, and elsewhere may be interested in a developing investigation into multiple cases of serious injury after the use of robotic devices in surgery. One woman who underwent a hysterectomy with a robotic surgical device suffered a punctured intestine, which led to septic shock and other issues. A man who went through prostate removal surgery with a robotic device suffered nerve damage to multiple limbs.

Though hospitals are supposed to report adverse events during surgery to the Food and Drug Administration, many events like these go unreported. The FDA isn't authorized to force hospitals to comply with reporting guidelines. A Bloomberg review of surgeries performed with a particular robotic surgical device found evidence of many injuries that went unreported for years. In some cases, the lack of reports and of disclosure of risks to patients led to further injury. A 45-year-old woman who underwent a hysterectomy using robotic surgical techniques and suffered a bad internal burn has had three corrective surgeries, and she is currently on disability. She alleges that she wasn't informed that the specific device used for her surgery had been previously linked to several serious injuries.

Many hospitals have minimal training requirements for doctors who are allowed to operate with robotic surgical devices. Surgeons receive a short training course, and they then perform a few trial procedures under expert supervision. The use of robots in surgery makes it difficult to distinguish between human error and injuries caused specifically by the robot. Chronic under-reporting of injuries makes it difficult to statistically assess the dangers of using robotic devices in surgery.

There are several pending cases of medical malpractice centered around robotic surgeries. Consultation with a lawyer skilled in the area of malpractice may be a good first option for an injured patient who is seeking compensation. It can be difficult to determine if hospitals are at fault for reasons of non-disclosure of dangers associated with the devices or if individual surgeons are responsible for surgical errors that cause severe injuries.

Source: Bloomberg, "Unreported Robot Surgery Injuries Open Questions for FDA", Robert Langreth, December 29, 2013

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