Following a gastrointestinal surgery, a California woman indicates she suffered a bowel leak and other complications when a surgical stapler malfunctioned, which was allegedly defective and prone to misfire, according to a recently filed product liability lawsuit.

The complaint (PDF) was brought by Lorraine Bonner in the U.S. District Court for the Northern District of California on September 19, claiming an Endo GIA stapler manufactured and sold by Medtronic and it’s Covidien subsidiary was unreasonably dangerous and failed to create staple lines that led to anastomotic leaks.

Bonner underwent sigmoidectomy surgery in November 2017, during which an Endo surgical stapler was used internally to connect healthy tissue. After the gastrointestinal procedure, Bonner was slow to regain bowel function and experienced other complications while in the hospital. After a bowel leak was suspected, Bonner was brought back to the operating room about a week later, and a second surgery was required due to the surgical stapler malfunction during the first procedure.

Several months after the Bonner’s complications, Medtronic and Covidien issued an Endo GIA stapler recall in May 2018, with additional products removed from the market in June 2019, due to known defects that may cause the surgical stapler to misfire.

“As a result of the defective stapler, Plaintiff was forced to undergo three additional surgical procedures,” Bonner’s lawsuit states. “Plaintiff has since learned that the stapler in question was likely recalled and that the FDA recently reported that surgical staplers, including those manufactured by Defendants, have been responsible for tens of thousands of adverse outcomes attributed to malfunctioning staplers.”

In March 2019, the FDA reported that at least 41,000 adverse event reports were filed between January 2011 and March 2018 involving surgical staplers, including 366 patient deaths.

Surgical Staples Lawsuits

The case is one of a growing number of surgical stapler recall lawsuits filed in recent months, as the FDA is continuing to review design problems associated with a number of devices and how the devices can be made safer for patients.

In April, the FDA proposed new rules and guidelines designed to make surgical staplers safer, and to classify them as moderate risk medical devices. They are currently classified as low-risk devices.

The new classification would require more stringent premarket approval for new staplers and force manufacturers to provide more thorough safety warnings and instructions.

The most commonly reported surgical stapler problems involve an opening of the staple line, malformation of staples, staplers misfiring, staplers being too difficult to fire, staplers failing to fire and staplers that were misapplied. The FDA warning indicates that stapler malfunctions or misuse can cause prolonged surgical procedures, the need for additional surgeries, and other complications; such as bleeding, sepsis, internal organ damage, and death.

Tags: Covidien, Medical Device Recall, Medtronic, Surgical Stapler