But the hidden database has included serious injury and malfunction reports for about 100 medical devices, according to the FDA, many implanted in patients or used in countless surgeries. Since 2016, at least 1.1 million incidents have flowed into the internal “alternative summary reporting” repository, instead of being described individually in the widely scrutinized public database known as MAUDE, which medical experts trust to identify problems that could put patients in jeopardy.ĭeaths must still be reported in MAUDE. The FDA has built and expanded a vast and hidden repository of reports on device-related injuries and malfunctions, a Kaiser Health News investigation shows. Douglas Kwazneski witnessed a surgical stapler malfunction, he surveyed leading surgeons and discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. “I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year.Īfter Dr. 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. Such failures can have deadly consequences.

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. Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. The surgical stapler meant to cut and seal the tissue around the appendix locked up. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. Additionally, in June 2019, the FDA released 5.7 million of the previously hidden malfunction and injury reports.ĭr. Soon after this story ran, the FDA began a review of surgical stapler safety. 7, 2021, and also reclassified the devices to increase oversight. This story can be republished for free ( details).Īn update on this series’ impact: The Food and Drug Administration issued updated guidance and sent a letter to health care providers on the safe use of surgical staplers on Oct. This story can be republished for free ( details).

This story also ran on Tampa Bay Times and Miami Herald.

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