Injuries Linked to Da Vinci Surgeries Underreported, Researchers Say

Cheryl Clark, for HealthLeaders Media , September 4, 2013

Now, however, a growing number of reports question its safety and effectiveness compared with traditional laparoscopy in gynecologic procedures.

Media representatives for Intuitive did not return a request for comment about the study Tuesday. At an investment conference, cited in a media report earlier this year, however,  Intuitive dismissed safety concerns, telling analysts that given the number of procedures it does, it believes its safety record is "exemplary."

Officials for the FDA have said they they are increasingly concerned about the safety of the Da Vinci system since a spike in the number of adverse events associated with the device reported last year.

The FDA earlier this year launched a survey to get physician's opinions about their use of the device, even as Intuitive faces several lawsuits and the FDA issued a recall in July of 30 robot devices.

For surgeons and patients, as well as hospitals, the issue presents an enormous problem because reporting of harmful events to the FDA is not mandatory.

"The main reason there aren't more reports, in my opinion, is that the FDA requirement to report adverse events has no teeth whatsoever in terms of enforcement," Makary says.

"It's like if you gave an exam to a classroom of students and said, 'grade your own exams, and we absolutely will not investigate anybody's authenticity of their scoring. And if you perform really well, there's a bonus, you'll be rewarded.'

"Essentially, that's the system we have now. Many times doctors will just leave it up to the industry, or to the manufacturer, to do the reporting."

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