Surgical Staplers to Face More Scrutiny From FDA After Injuries (1)

Surgical staples and staplers contributed to over 9,000 serious injuries and 366 patient deaths last year, the FDA said in an April 23 announcement.

These devices reportedly popped open, performed abnormally, were applied incorrectly, got stuck or wouldn’t fire, according to the 41,000 medical device reports in 2018.

The Food and Drug Administration said its draft guidance, to be published in the Federal Register April 24, will help patients avoid malfunctions, injuries, and deaths linked to these products. Surgical staplers and staples can be used to remove, cut through, and connect organs and tissues.

Ethicon Inc.'s hemorrhoidal circular stapler was ...