FDA issues letter on risks linked with staplers, implantable staples

Editor's Note

The Food and Drug Administration (FDA) on March 8 issued a letter to alert healthcare providers about an increasing number of medical device reports on surgical staplers for internal use and implantable surgical staples.

The most common reported problems include opening of the staple line, malformation of staples, staple misfiring, difficulty in firing, failure of the stapler to fire, and misapplied staples.

In the letter, the FDA reminded providers to review labeling instructions and indications for use. The letter also suggests that providers consider alternative options if the patient’s tissue is swollen, prone to bleeding, or necrotic. The FDA further provides recommendations on recognizing and managing device malfunction.