Surgical Staplers Put Patients at Risk for Bleeding, Sepsis, and Death

On March 8, 2019, the FDA sent a letter to health care providers because of concerns regarding an increasing number of adverse events associated with surgical staplers.  From January 1, 2011, to March 31, 2018, the FDA received over 41,000 individual medical device reports for these devices, including:

• 366 deaths,
• over 9,000 serious injuries,
• and over 32,000 malfunctions.