Surgical staplers can make life easier for both patients and doctors. These days they are often used instead of sutures and relied upon at hospitals for several procedures ranging from simply closing a skin wound to removing a part of an organ like a lung or heart.
While the benefits of the medical devices are clear, there is no doubt that if there is a misstep, the results could be catastrophic. A surgical stapler’s malfunctioning could cause many different types of injuries, including serious bleeding, sepsis, and even death.
In 2019, the ECRI Institute, an organization advocating for patient safety, identified surgical stapler mishaps as the number one health technology hazard for the upcoming year. In an article titled, “Top 10 Health Technology Hazards for 2020,’’ Dr. Marcus Schabacker, the institute’s president, stressed that a misfired staple could have horrific results and indeed, the malfunctions could be substantial, yet at the same time, “preventable.”
In 2019, the U.S. Food and Drug Administration (FDA) addressed the negative issues surrounding surgical staplers in a letter to medical professionals across the country. In it, the agency shared seven years of data revealing a wide range of problems.
The FDA’s research, based on information from medical device reports between January 1, 2011, and March 31, 2019, found improper functions or improper uses of surgical staplers were related to:
- 366 deaths,
- over 9,000 serious injuries, and
- over 32,000 malfunctions.
While the FDA’s efforts, combined with a continued push by safety organizations like the ERCI Institute, have brought more awareness to surgical staplers’ hazards, recent actions have also included a major upswing in the number of recalls of surgical staplers.
In the last several years, the two largest producers of surgical staplers, Medtronic and Ethicon, have been forced to recall more than 3.4 million staplers, staples and components.
Here is a sampling of recent stapler recalls:
- Ethicon/Echelon 60 mm endoscopic linear cutter reloads, black; In 2013, 57,540 staplers were recalled due to the potential of reload issues, preventing a complete line of staples 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.