A Recall on Surgical Staplers Due to Patient Deaths

Surgical staplers are devices used to cut and staple internal tissue throughout a wide variety of surgeries. Unfortunately, between January 1st, 2011 and March 31st, 2018, the U.S. Food and Drug Administration (FDA) reported that out of 41,000 staples used, 32,000 staples malfunctioned resulting in over 9,000 injuries and 366 deaths.

This level of product failure is simply unacceptable. The 9,000 injured patients suffered through serious medical complications including:

  • ·         Bleeding
  • ·         Sepsis
  • ·         Fistula formation
  • ·         Tearing of internal tissues and organs
  • ·         Sealing of untargeted tissues
  • ·         Increasing risk of cancer recurrence
  • ·         The need for a permanent ostomy “bag”
  • ·         The need for additional closures (anastomoses)
  • ·         Leaks in the closure (anastomotic leak)
  • ·         Life-long nutritional and digestive issues
  • ·         Death

In a letter sent to healthcare providers in March or 2019, the FDA stated: “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 staple."

The risks of complications associated with the staplers may be linked to device defects, which prompted certain manufacturers such as Ethicon to recall their products.

Over the past several years, Medtronic and Ethicon have been forced to recall over 3.4 million staplers, staples, and components. 

These recalls include:

  •         Ethicon/Echelon 60 mm endoscopic linear cutter reloads - In 2013, 57,540 staplers were recalled due to the potential of reloading issues, preventing a complete line of staples from firing. 
  •       Ethicon/Endopath Echelon Flex Powered Vascular Staplers with Advanced Placement Tip and White Reloads - In 2015, 6,744 injuries were reported. Inspections found certain staplers may not insert a full line of staples when fired.
  •          Medtronic Endo GIA Auto Suture Universal Articulating Loading Unit - In 2018, 171,271 staplers were recalled when five people sustained injuries relating to missing components affecting staple alignment. 
  •          Medtronic Endo GIA Articulating Reloads with TriStaple Technology - In 2019, more than 3-million staplers were recalled due to missing components.
  •          Ethicon Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and the Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples; Also, in 2019, two patients were injured after devices misfired and cut portions of their rectums. In total, 92,496 devices were recalled.

Unfortunately, many patients who have received surgical staples in the past may have yet to experience complications, but will in the future.

If you or a loved one has experienced any complications due to defective surgical staplers, please contact our New York attorneys. Rheingold, Giuffra, Ruffo & Plotkin LLP has over 50 years of experience specializing in defective medical devices. We will do a detailed investigation to determine the manufacturer of the stapler as well as investigate if healthcare providers did not diagnose the complications quickly enough. We are here to guide you through this difficult time and get you the justice you deserve. Please contact us today for a free consultation.

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