Covidien Stapler Malfunctioned During Surgery, Leading to Tissue Damage and Hospitalization: Lawsuit

Medtronic and it’s Covidien subsidiary face a product liability lawsuit filed by a North Carolina woman, who indicates she was left with severe injuries when a surgical stapler malfunctioned, resulting in tissue damage and the need for additional surgeries.

The complaint (PDF) was filed by Kimberly Bell in Massachusetts federal court on September 9, indicating that an Endo GIA 45mm stapler with Tri Staple Technology malfunctioned during surgery, causing a “tear” in the surgical area, leading to prolonged hospitalization and extensive medical care.

The case joins a growing number of surgical stapler lawsuits being pursued against Covidien and other manufacturers, each raising similar allegations that design defects caused the devices to misfire, fail to fire or issue malformed staples, which can cause devastating internal injuries and organ perforations.

The lawsuit indicates Bell underwent a laparoscopic biliopancreatic diversion and hernia repair in September 2019, at which time the Covidien stapler malfunctioned. Following additional surgical procedures to repair the damage, Bell indicates she suffered nausea, vomiting and hypertension, followed by shortness of breath and worsening abdominal pain, as well as poor urinary output. She then became hypotensive, suffering from low blood pressure. She was diagnosed as suffering an anastomotic leak due to a tear at the apex staples, measuring 5 mm.

“This anastomotic leak led to Ms. Bell’s development of acute respiratory failure and pulmonary edema leading to septic shock,” the lawsuit states. “After her procedure on September 14, 2019, Ms. Bell was transferred to the critical unit for medical intensive care and vent management, Ms. Bell was on a ventilator for seven (7) days. She required several liters of Lactated Ringer’s solution and developed acute kidney injury which required her to start intermittent hemodialysis.”

Later that month she suffered atrial fibrillation, and spent a total of 30 days in the hospital, including two weeks in critical care and another week on a ventilator. She was then released to a rehabilitation facility for another two weeks, followed by about two weeks of home health care.

Surgical Stapler Problems

In March 2019, the FDA reported at least 41,000 adverse event reports involving surgical stapler failures were filed between January 2011 and March 2018, including 366 patient deaths. However, it appears that those reports did not include all problems linked to the devices.

As part of an effort to make surgical staplers safer, the FDA issued new rules and guidelines for Covidien and other manufacturers, and has to reclassified staplers as Class II surgical devices, which now requires any new surgical staplers to undergo premarket review before getting FDA approval.

The change of surgical staplers from class I medical device (general controls) to class II medical devices (special controls) has been anticipated for several years, and does not affect the classification of the staples themselves. However, it would require more stringent premarket approval for new staplers and force manufacturers to provide more thorough safety warnings and instructions.