FDA Flags 41,000 Adverse Event Reports Linked to Surgical Staplers, Staples

Regulatory NewsRegulatory News
| 08 March 2019 | By Ana Mulero 

The US Food and Drug Administration (FDA) sent a letter to health care providers Friday over a growing body of adverse events associated with surgical staplers and implantable staples.
The agency’s ongoing analysis of medical device reports (MDRs) found that it received more than 41,000 individual MDRs that describe adverse events associated with the use of surgical staplers and staples for internal use between 1 January 2011 and 31 March 2018.
These include 366 deaths, almost 9,000 serious injuries and over 32,000 malfunctions. The letter also notes FDA is aware “many more device malfunction reports” were submitted during this same time frame as alternative summary reports and is still analyzing both these reports and the MDRs.
The letter follows on the heels of a Kaiser Health News (KHN) investigation released Thursday and detailing the agency’s alternative summary reporting program for medical devices. The KHN investigation found that the repository has reportedly “included serious injury and malfunction reports for about 100 medical devices,” though neither of these event types are covered by the scope of the exemption of FDA’s alternative reporting program.
The program was revamped in 2017 as the Voluntary Malfunction Summary Reporting Program as an alternative for eligible quarterly report submissions in summary formats. It was expanded last August to include combination products, despite pushback on the 2017 program proposal.
KHN investigation reported the “hidden repository” included surgical staplers. But “these devices are not currently eligible for alternative summary reporting or Voluntary Malfunction Summary Reporting,” FDA said.
Commonly reported adverse events in the evaluated MDRs include misfiring, staple malformation and failure of the stapler to fire the staple. FDA said it “believes that many of the problems identified in these reports can be primarily attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler.” It intends to issue draft guidance this year to propose device labeling recommendations.
The agency also plans to hold a public meeting of the Medical Devices Advisory Committee’s General and Plastic Surgery Devices Panel for open discussion around whether it would be appropriate to reclassify surgical staples for internal use from its current class I medical device classification into class II. The reclassification would in turn allow FDA to mitigate known risks of the device type by establishing mandatory special controls and requiring 510(k) submissions.
Health care providers were offered seven recommendations. These relate to following the stapler manufacturer’s instructions for use, having of a range of staple sizes available, considering other suturing options and avoiding use on large blood vessels, among several other recommendations. 



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