Surgical staplers employ surgical staples internally and externally to close deep wounds and connect anatomical structures (anastomosis) during surgery—particularly in gastrointestinal tract procedures. Used in place of sutures, surgical staples reduce the size of a wound, the body’s inflammatory response and the duration of recovery and healing. However, when the staples do not close correctly, a patient can experience life-threatening consequences.
The Food and Drug Administration (FDA) has issued a Class I recall of Ethicon Endo-Surgery Intraluminal Circular Staplers. Following physician complaints and the return of stapler products, an investigation found that uncut washers in these Ethicon devices were causing staples to change form due to insufficient firing. The defect in the Ethicon staplers was caused by a manufacturing shift that occurred between March 2018 and March 2019.
Class I recalls are issued for products that have a reasonable probability for leading to serious adverse health consequences or death with use. The Class I recall for Ethicon Endo-Surgery staplers includes the following products:
- Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples
- Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
- Product Codes: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A (Product codes are located on the front of the single unit carton.)
- 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
Malformed staples present health risks to patients, and there have been multiple reports of serious injuries resulting from the use of this Ethicon device. The misfiring of the surgical staples from the Ethicon stapler can lead to:
- Leaks in the closure (anastomotic leak)
- Severe bleeding
- A need for a permanent ostomy bag
- Life-long nutritional and digestive issues
- A need for additional closures and revisions
- Multiple infections
- A need for additional medication and imaging
Slater Slater Schulman LLP is dedicated to the representation of individuals who have been injured by the use of surgical staples from the Ethicon Endo-Surgery surgical staplers. Our firm is handling litigation related to these claims nationwide.
If you or someone you love has been injured as a result of the use of an Ethicon Endo-Surgery stapler, please contact Slater Slater Schulman LLP for a free consultation by filling out the form on this page or by calling our office at (800) 251-6990.