The United States Food and Drug Administration (FDA) has identified a recall of circular staplers by Johnson & Johnson's subsidiary, Ethicon, as Class I, which is the most serious type of recall. The use of these devices may cause serious injuries or death.
Recalled Product
- Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and
- Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
- Product Codes: CDH21A, CDH2sA, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A
- Manufacturing Dates: March 6, 2018, to March 6, 2019
- Distribution Dates: March 15, 2018, to March 8, 2019
- Devices Recalled in the U.S.: 92,496
- Date Initiated by Firm: April 11, 2019
Initiated earlier this year, the recall involved a total of 92,496 Endo-Surgery Curved and Endo-Surgery Endoscopic Curved Staplers used in the gastrointestinal tract to create connections between structures in surgical procedures.
The staplers were found to be defective in that they contained uncut washers causing malformed staples to occur with their intraluminal circular staplers due to insufficient firing. This can compromise staple line integrity.
Additionally, an investigation of the manufacturing process found a shift in the procedure that occurred from March 2018 through March 8th, 2019.
The defected Ethicon surgical staplers may cause patients serious harm or even death. There have been serious injuries to two patients due to the misfiring of the stapler confirmed by Ethicon.
"Misfiring of the stapler resulted in an additional resection -- of the middle rectum in one patient and the lower rectum in another patient -- during the planned resection of the upper rectum," the FDA's statement reported.
Potential risks of the defective stapler include death, sepsis, bleeding, the need for a permanent ostomy bag, permanent nutritional and digestive issues, leak in the closure, additional surgeries, need for additional closures, need for antibiotics, and the need for additional imaging studies.
Faraci Lange's personal injury attorneys have successfully represented hundreds of clients who have been injured as a result of defective medical devices.
