Surgical staplers cut and seal blood vessels and tissue, often during minimally invasive surgeries.
When the staplers fail to fire, patients have bled profusely and suffered dire injuries or death. The FDA said stapler malfunctions or misuse can lead to “bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.”
The FDA has received over 41,000 individual medical device reports for surgical staplers and staples for internal use from 2011 to 2018, 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. The most reported problems in these reports include:
- opening of the staple line or malformation of staples
- difficulty in firing
- failure of the stapler to fire the staple
- misapplied staples
Stapler and staple malfunctions or misuse may result in prolonged surgical procedures or unplanned, additional surgical procedures, which may lead to other complications, such as:
- fistula formation
- tearing of internal tissues and organs
- increased risk of cancer recurrence
The agency also said that changing the classification of surgical staplers could allow the agency to require “performance testing of various mechanical features” and special labeling. This could create safer staplers and result in safer procedures.
At Carr and Carr, our defective medical device attorneys understand complications caused by defective medical devices can be devastating. We have helped those who have suffered, and we can help you too.