Injured by a surgical stapler: What you need to know

Surgical staplers are medical instruments used during surgeries in place of sutures to close incisions or connect internal organs. These instruments have been in use for decades.

However, these devices may be more dangerous than it was previously known. A review of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database has found that tens of thousands of adverse events reports have been filed over the use of these devices between January 1, 2011 and March 31, 2018.

According to a letter from the FDA to health care providers, the review found that surgical staplers have malfunctioned more than 32,000 times, and that in more than 9,000 cases, patients were seriously injured by a surgical stapler. On top of these injuries, there were 366 deaths.

The FDA noted that in most of the reports where a patient was injured by a surgical stapler, the issue could be attributed to internal use.

Commonly reported problems in these adverse event reports included:

• Opening of the staple line or malformation of staples
• Misfiring
• Difficulty in firing
• Failure of the stapler to fire the staple
• Misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue)

The malfunction or misuse of a surgical stapler can lead to prolonged surgery or additional surgeries, which in turn can lead to a number of serious complications, according to the FDA. These include:

• Bleeding
• Sepsis
• Fistula formation
• Tearing of internal tissues and organs
• Increased risk of cancer recurrence
• Death

The FDA also admitted that there were many more device malfunction reports during this timeframe than just the ones accessible via MAUDE, because they were submitted instead as Alternative Summary Reports. Indeed, somewhere around 56,000 surgical stapler malfunctions were reported to the agency between 2011 and 2018 but were not initially acknowledged by the agency as contributing to its numbers. With these reports included, the actual number of patients who were injured by a surgical stapler or otherwise had a stapler malfunction was not 41,000, but closer to 110,000.

Certain surgical staplers have been recalled. A major recall was issued by the FDA in May 2019 for Ethicon Intraluminal Staplers used in gastrointestinal surgeries. The recall was designated as Class 1, meaning that there is a high probability of the device causing serious injury or death. More than 92,000 units sold in the U.S. starting in March 2018 were affected by the recall. Other, smaller recalls have been issued for certain Covidien surgical stapler devices.

If you or someone you love has been injured by a surgical stapler, you may be able to file a surgical stapler lawsuit and pursue compensation.