Surgical Stapler Recall: What You Should Know
Article Provided by Richard S. Jaffe
Attorney at Cohen & Jaffe LLP
Surgical staples play a critical role in many medical procedures. Skin staples are medical devices that can externally close wounds under high tension. Besides minimizing quick tissue reaction, surgical staples can also be quickly placed and pose a low risk of infection.
For the most part, surgical staples can successfully close patient’s bodies. A Class 1 recall, however, was recently issued by the FDA for one type of surgical stapler. A Class 1 recall occurs when there is a reasonable probability that the use of a product will result in adverse health consequences or even death. This is considered the most serious type of recall, which is why this article briefly explains some important things you should know about the situation.
What Products are Recalled
The products recalled are certain types of Echelon Flex Staplers. More specifically, the staplers recalled are Echelon Flex 60 Endopath Stapler (Product Code EC60A), Echelon Flex 60 Powered Plus Compact Stapler (Product Code PCEE60A), Echelon Flex 60 Powered Plus with a 44 cm shaft length (Product Code PLEE60A), and Echelon Flex 60 Powered Plus with a 34 cm shaft length (Product Code PSEE60A). These 5,733 products were distributed from August 1 to September 26, 2019. The staplers are used to cut and staple internal tissue during minimally-invasive surgical procedures.
The Reason for the Recall
The Echelon stapler is being recalled because some contain an out-of-specification component in their jaw which could result in malformed staples. If this type of problem is not promptly recognized, there is a risk of prolonged surgery, post-operation leaks, hemorrhages, shock, the need for additional surgical intervention, and death. At least seven serious injuries and one fatality have already been attributed to the staplers. The group of people who might be affected by these defective staplers includes those who underwent surgery in 2019 requiring internal staples. Surgeons who have performed or who will perform surgeries using internal staples are also at risk.
What to do if You are Impacted by the Recall
In October 2019, Ethicon sent out a letter to customers who purchased the stapler, which contained instructions about how to respond. Impacted parties must:
- Review their inventory if they have the recalled product. If they do, these parties must quarantine the product.
- Communicate details about the issue to relevant operating rooms or material management workers.
- Contact anyone at another facility who received the defective product.
- Complete a Business Reply Form confirming receipt of the letter. This must occur within three business days of receiving the letter. Entities must do this even if they do not have any of the recalled products.
- Keep the letter posted so other parties are aware of the recall.
- If customers have the recalled product, they must return them immediately. The customers are then provided with replacement products.
About the Author
Richard S. Jaffe, esq. of the Law Office of Cohen & Jaffe, has been fighting for rights and justice for clients injured by dangerous devices and products.
The Law Office of Cohen & Jaffe, LLP is a Long Island, NY law firm representing clients in personal injury, car accidents, medical malpractice, mass torts, employment law and other cases. Their knowledge and experience in various practice areas allows them to help victims that were injured due to the neglect of another. Call 516-358-6900 today to schedule your free consultation.