Ethicon is recalling 92,496 surgical staplers because they can malfunction and cause serious injury or death to patients.
Affected devices include the Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and the Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples. These staplers were used during gastrointestinal surgery, such as colorectal cancer or bariatric surgery, to create connections between structures.
Ethicon launched an investigation into complaints and returned products and confirmed the devices could insufficiently fire, resulting in uncut washers and malformed staples. This can compromise the integrity of the staple line. The company also detected an error in the manufacturing process, which occurred in March 2018 and continued through March 8, 2019, when the line was shut down.
Ethicon has confirmed that two patients who underwent planned resection of the upper rectum suffered serious injuries due to misfiring. One patient required additional resection of the middle rectum and the other required additional resection of the lower rectum.
Potential risks to patients include death, sepsis, bleeding, the need for permanent ostomy “bag,” life-long nutritional and digestive issues, leak in the closure, additional surgeries, need for additional closures, need for antibiotics, and need for additional imaging studies.
The recall notice comes about three weeks after the FDA announced that new actions to curtail the number of malfunctions, injuries and deaths associated with surgical staplers and staples for internal use after learning that there had been more than 41,000 medical device reports involving the devices from Jan. 1, 2011, to March 31, 2018, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 device malfunctions.
Surgical staplers and staples for internal use are used in a wide range of surgical applications besides gastrointestinal surgeries. They are also used for gynecologic and thoracic surgeries to remove part of an organ, to cut through organs and tissues, and to create connections between structures.
Anyone who has suffered injuries due to surgical stapler malfunction should file a report with the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program, and should consider consulting with an attorney.