Archive April 2019 XX, No. 4

FDA Shocked by Spike in Malfunctioning Staplers

Devices that misfired or failed to fire have injured or killed thousands.

Mike Morsch

Mike Morsch, Associate Editor

BIO

IN THE LINE OF FIRE
Stephen Moyer
IN THE LINE OF FIRE The FDA is concerned by the increasing number of adverse events associated with surgical staplers and staples.

It's no secret that a stapler failure can quickly turn a routine procedure into an emergency. What's surprising is the alarming number of times staplers have misfired or failed to fire — and the number of patients that have been harmed or killed as a result. Over the last 7 years, malfunctioning surgical staplers have seriously injured more than 9,000 patients and killed 366 others, according to an analysis by the U.S. Food and Drug Administration, which last month sent healthcare professionals a letter warning them of the dangers (osmag.net/rAcBP5).

From Jan. 1, 2011, to March 31, 2018, the FDA says it received reports of more than 32,000 stapler and staple malfunctions. Among the most commonly reported problems: the opening of the staple line or malformation of staples; misfiring; difficulty in firing; failure of the stapler to fire staples; and misapplied staples (user applying staples to the wrong tissue or applying staples of the wrong size to the tissue.)

Stapler and staple malfunctions could result in prolonged surgical procedures or unplanned additional surgical interventions which may lead to complications, such as bleeding, sepsis, fistula formation, tearing of internal tissues and organs, increased risk of cancer recurrence and even death.

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