Surgical staplers and staples can be more effective than traditional stitches for big or complex wounds. Staples allow for quick placement and strong wound closure with minimal tissue reaction and a low risk of infection. Staplers and staples can be used internally and externally.[1] While there are many advantages to using staples over traditional stitches, there are many risks as well. The FDA reports most issues with staplers come from being utilized internally. From 2011 to 2018, over 9,000 serious injuries and 32,000 malfunctions from surgical staplers and staples were reported to the FDA.[2] If you or a loved one was injured from a surgical stapler complication, contact Counsel Hound today for a no-cost consultation and case evaluation.

Common Problems

According to the FDA, commonly reported problems with surgical staples include:[3]

  • Misapplied staples
  • Stapler misfiring
  • Difficulty in firing stapler
  • Stapler failing to fire
  • Staple line opening
  • Malformation of staples

Complications

The FDA also reports that surgical staple malfunctions may lead to the following complications:[4]

  • Bleeding
  • Sepsis
  • Fistulas
  • Torn internal tissues and organs
  • Increased risk of cancer recurrence
  • Death

FDA Recalls

In April 2019, the FDA issued guidance to provide labeling recommendations for surgical staplers and staples for internal use due to malfunctions and misuse causing serious complications and death. The FDA also proposed reclassifying surgical staplers from Class I to Class II medical devices. This would allow the FDA to establish mandatory special controls and require premarket notifications.[5]

The FDA issued a recall of Ethicon Endo-Surgery Intraluminal Staplers in April 2019, two weeks before the new labeling guidance was released. The recall was identified as the most serious type of recall, Class I recall. The FDA warns that the use of Class I recall may result in serious injuries or death.[6]