FDA said today that it has received more than 41,000 adverse event reports — including 366 deaths — associated with surgical staplers and staples for internal use, and that it may require stricter product review of the devices.
The agency’s ongoing analysis of stapler- and internal-staple-related adverse event reports from Jan. 1, 2011 to March 31, 2018, also revealed more than 9,000 serious injuries and over 32,000 malfunctions. FDA attributed many of the problems to the staplers themselves because proper staple formation depends largely on proper function and use of the stapler.
FDA also said that “many more” surgical stapler and internal staple malfunction reports made during the same period came in as “alternative summary reports,” which are inaccessible to the public, even though they were ineligible for such a designation. Kaiser Health News reported yesterday that FDA is hiding millions of medical device adverse event and malfunction reports from the public in its summary reporting repository. Since 2016, at least 1.1 million such reports have gone into that repository, the news service reported.
Some of the most commonly reported problems associated with surgical staplers and internal-use staples listed in the publicly available adverse event reports include:
- Opening of the staple line or malformation of staples.
- Misfiring, difficulty in firing or failure of the stapler to fire the staple.
- The application of staples to the wrong tissue or using the wrong size staples.
Stapler and/or staple malfunctions or misuse may prolong surgical procedures or lead to unplanned, additional interventions, which may lead to other complications, such as bleeding, sepsis, fistula formation, tearing of internal tissues and organs, increased risk of cancer recurrence, and death, the agency said.
In a letter to healthcare practitioners, William Maisel, M.D., chief medical officer of FDA’s Center for Devices and Radiological Health (CDRH), made several safety recommendations. FDA said intends to issue a draft guidance on product labeling for surgical stapler and internal-use staple manufacturers later this year.
It also plans to hold a public meeting to discuss whether to reclassify surgical staplers for internal use as Class II medical devices, which would require them to undergo the agency’s strictest evaluation, the premarket notification review (PMA). FDA currently regulates all surgical staplers as Class I devices, which do not require a PMA review. Such a reclassification would allow FDA to establish mandatory special controls to help mitigate known risks of the device.
“We are conducting an ongoing analysis of both (the alternative summary) reports and of medical device reports received since March 31, 2018,” FDA said in a prepared statement. “The results of this analysis, when complete, will be available to the public along with the materials for the upcoming advisory committee meeting. These devices are not currently eligible for alternative summary reporting or voluntary malfunction summary reporting.”
FDA said it will announce the meeting, including details about how to participate, on its advisory committee calendar webpage and in a Federal Register notice at least 15 days prior to the scheduled date.
