Surgeon and patient in operating room

Surgical staplers have been around for more than 50 years. Heavily marketed as time savers, health care professionals prefer to rely on this medical device because it has been known to provide convenience in closing wounds and incisions.

Lately, however, surgical staplers have been linked to a number of serious injury and complication due to defective staplers manufactured by companies.

In fact, this medical device has been the target of many lawsuits recently filed in the United States.

Plaintiffs who have filed a surgical stapler lawsuit claim that a defective surgical stapler can potentially fail or malfunction, causing severe injury and even death to a patient.

Why are surgical staplers becoming a cause for concern in the medical field? Just recently, misuse of surgical staplers even topped ECRI Institute’s list of technology hazards.

Read on to learn more about complications from surgical stapler misuse and find out why news about this medical device has been making the rounds lately.

What Types of Injuries Do Surgical Stapler Malfunctions Cause?

A surgical stapler malfunction during surgery can cause injury or complications including internal bleeding, infection at the incision site, damage to or tearing of internal tissue and internal organs, sepsis, blood loss, fistula or an abnormal connection between tissue and organs, increased risk of cancer recurrence, and even death.

These surgical stapler injury or complications are due to instances of surgical stapler malfunction, misuse, and misfiring. These problems can result in prolonged surgical procedures which puts the patient at risk of additional injury because of being under the effect of anesthesia longer than what was originally planned.

This medical device is often used in minimally invasive surgeries as it is meant to both cut tissue and blood vessel and quickly seal them afterwards.

However, in some cases, surgical staplers can gravely harm a patient when it fails to fire or seal a tissue. This can result in massive bleeding or infections.

And the numbers speak for themselves:

According to the Manufacturer and User Facility Device Experience (MAUDE) Database of the U.S. Food and Drug Administration, over 41,000 medical device reports were received by the agency on surgical stapler and staple malfunctions, including:

  • 366 deaths
  • 9,000 serious injuries

These numbers, however, only represent what the FDA has admitted in public. According to an investigative report by Kaiser Health News, over 56,000 malfunction reports filed by several surgical stapler manufacturer were not disclosed to the public.

An FDA spokesperson tried to defend the hidden database by saying that its purpose was to allow the FDA to “more efficiently review adverse events and take action where warranted without sacrificing the quality of our review or the information we receive.”

However, this hidden database made it difficult for health care providers to assess patient safety in using the medical device for surgical procedure.

Surgical Stapler Misuse Tops Technology Hazards Report for 2020

The ECRI Institute is an independent health safety group that maintians a database of hospital-reported adverse event.

The nonprofit recently released its Top 10 Technology Hazards report, where it identified surgical stapler misuse as the number 1 health technology concern of 2020.

The reason why it topped the list?

Because of the FDA’s analysis of stapler incidents in their database. Out of the large range of numbers that we mentioned earlier, 75 of those stapler accidents were investigated by the ECRI.

Most of the cases that the group investigated were due to the complexity of using the medical device. For instance, surgeons need to accurately choose the correct size of staple for the type of tissue they are going to work with in a surgery.

Moreover, staplers used in a laparoscopic surgery are meant or designed to staple tissue together and cut in between the staple line. If that line isn’t closed, it could result in leakage.

“Injuries and deaths from the misuse of surgical staplers are substantial and preventable,” ECRI Institute CEO Dr. Marcus Schabacker said in a statement. “We want hospitals and other medical institutions to be in a better position to take necessary actions to protect patients from harm.”

Reports of Surgical Stapler Malfunctions

According to the FDA, achieving a proper staple line depends on the function and proper use of the surgical stapler.

If in case, the staple line is incomplete, bleeding at the incision site and reopening of the wound may be possible.

The most common malfunctions from surgical staplers reported to the FDA include:

  • misfiring
  • difficulty in firing
  • failure of the stapler to fire the surgical staple
  • opening of the staple line at the wound site
  • using the wrong size of staple to tissue
  • application of staples to the wrong tissue
  • malformed staples that create incomplete seals

These malfunctions may cause more surgical stapler complications which may require a patient to undergo additional surgical intervention. These accidents may also be life threatening as the patient may eventually bleed out and die when a tissue is left open.

Ethicon Surgical Stapler Recall

There has been a number of recalls on a number of Ethicon surgical stapler which were found to be unsafe.

The most recent one, however, was made by the company in 2019 when it pulled off the Intraluminal circular stapler from the market due to insufficient firing and failure to completely form staples.

The Ethicon stapler recall affected 92,496 intraluminal staplers manufactured and distributed from March 6, 2016 until May 8, 2019.

The FDA designated the recall as Class I, which means that the particular Ethicon stapler causes serious side effects and dangers, even death.

Another surgical stapler manufacturer, Covidien, a subsidiary of Medtronic, where part of the majority of surgical staplers used in American hospitals come from, is speculated to be aware of the problems associated with surgical staplers, yet reports of serious injuries keep coming with the continuous use of surgical stapler in medical facilities.

All in all, between 2013 and 2019, surgical stapler manufacturers have pulled off more than 3.4 million surgical staplers and staples from the market, including cartridges and components.

Adverse event reports ranged from defects that resulted in patient injuries to defective designs of the devices caught by the companies during manufacturing.

What You Can Do

According to surgical stapler lawsuits brought to the attention of the court, plaintiffs accuse companies of manufacturing the potentially faulty medical device, citing its defective designs.

Various reports of surgical stapler injury support this claim. The manufacturers, however, like to point the blame at health care providers and would turn a blind eye to the defective surgical staples and staplers.

If you or your loved one suffered from side effects of a malfunctioning surgical stapler that needed additional surgery, or sustained injuries related to defective surgical stapler, then you can contact us for a free case evaluation. If you qualify for a case, we may be able to connect you with a surgical stapler lawyer who can help you file a surgical staple lawsuit today.

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