FDA Probes Docs Over da Vinci Robot Problems
While the FDA isn't revealing numbers, Rivers emphasized that the "increases in reporting can be due to a number of factors, including an increase in the number of devices being used—as well as an increase in awareness of how to report device issues to the FDA."
To get a better sense of how to interpret the da Vinci reports, the FDA is surveying a "small sample of surgeons" who use the da Vinci system. "Since it is difficult to know why the reports have increased, FDA has elected to talk with surgeons to better understand the factors that may be contributing to the rise in report numbers," Rivers says.
The surveys are considered a "routine part of surveillance" and one of several postmarket tools that the FDA uses to help evaluate device performance and use and to "further understand the risk-benefit profile for devices."
"Increased publicity resulting from product recalls, media coverage, litigation, and other influences can also increase the number of reports, but this doesn't necessarily indicate a true rise in event occurrence," Rivers explains.
And because reports submitted to the FDA can contain "incomplete, inaccurate, duplicative, and unverified information, an upward trend of adverse event reports is not by itself directly indicative of a faulty or defective medical device," she says.
As part of the survey, the FDA is interested in questioning surgeons who use the da Vinci device for "a variety of procedures." The agency sent a letter to surgeons at hospitals that participate in the FDA's center for devices and radiological health's Medical Product Safety Network, known as MedSun.
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