Surgical Staplers

From January 1, 2011 to March 31, 2018, the FDA received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including:

• 366 deaths
• Over 9,000 serious injuries
• Over 32,000 malfunctions

The FDA believes that many of the problems identified in these reports can be primarily attributed to surgical staplers for internal use because proper staple formation is largely contingent on proper function and use of the stapler.

Some of the most commonly reported problems include:

• Opening of the staple line or malformation of staples
• Misfiring
• Difficulty in firing the staple
• 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)

Stapler and/or staple malfunctions may lead to other complications, such as:

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

Taking legal action enables individuals to hold large doctors and hospitals accountable for their actions and training, possibly reducing the risk of others experiencing the same complications. It also helps victims who suffer injuries or families of loved ones who have died obtain fair financial compensation for their damages.