Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

March 7, 2019 – Kaiser Health News – Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up.

Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.

Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view.

“I don’t want to sound over-dramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.

Madris Tomes, founder and chief executive of Device Events, was a contributor to this article.  Device Events is the only tool that enables healthcare providers to find and analyze the hard-to-find “alternative summary reports” discussed in this article. 

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