WASHINGTON — One day after Kaiser Health News published a blistering report on widespread problems with surgical staplers that had been reported to the FDA — but kept in a nonpublic database — the agency said Friday that it’s “concerned” by the problems and is taking steps to correct them.
In a “Dear Health Care Provider” letter, the FDA said it was conducting an analysis, “which is ongoing, [finding] that from January 1, 2011 to March 31, 2018, the FDA received over 41,000 individual medical device reports for surgical staplers and staples for internal use.”
Among them were reports of 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions, the letter said.
Common problems included malformed staples and misfiring, but issues related to what could be operator error — such as “applying staples to the wrong tissue or applying staples of the wrong size to the tissue” — were also frequent.
Kaiser Health News reported Thursday that manufacturers of surgical staplers, and many other types of devices, had requested and received special exemptions allowing them to report such malfunctions “in a database hidden from doctors and from public view.”
One physician quoted in the story said he was perplexed when he couldn’t find any such reports in the FDA’s main database for device-related adverse events, even though he knew many surgeons had experienced them. “I don’t want to sound overdramatic here, but it seemed like a cover-up,” he told KHN.
In fact, the online publication found, “at least 1.1 million incidents have flowed into the internal ‘alternative summary reporting’ repository” since 2016.
The FDA’s “Dear Provider” letter gave no indication that the agency plans to make all such reports more accessible, although it did suggest manufacturers may have abused the exemption program. “These devices are not currently eligible for alternative summary reporting or Voluntary Malfunction Summary Reporting,” the letter said.
Steps the agency said it will take include new advice to manufacturers on stapler labeling. The letter also instructed physicians to pay close attention to current labeling and to ensure they “have a range of staple sizes available.”
Finally, the FDA said it will convene an advisory committee meeting later this year “to discuss whether reclassifying surgical staplers for internal use as Class II medical devices would be appropriate.” Currently they are designated as Class I, the lowest-risk category for medical devices.