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As various manufacturers continue to face increasing reports of severe complications from surgical staplers, Ethicon is recalling another product, which the manufacturer indicates may contain a defective component that could produce malformed staples.
This week, the FDA announced an Echelon Flex 60 Endopath Stapler recall, which impacts more than 8,000 devices used in a wide variety of surgical procedures to both cut and staple internal tissue.
The action has been categorized as a class 1 medical device recall, which suggests that continued use of the single-patient staplers poses a risk of severe injury or death. At least seven serious injury reports have already been linked to problems with the Ethicon staplers, including at least one death, according to the FDA.
Ethicon is recalling the staplers because they may have an out-of-specification component within the device’s jaw, which can result in malformed staples. As a result of these complications, patients may experience prolonged surgery, anastomic leaks, hemorrhage, hemorrhagic shock, the need for additional surgical procedures, or wrongful death.
The manufacturer sent a letter to customers on October 3, announcing the recall, which impacts the Echelon Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter with a product code of EC60A; the Echelon Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, with product code PCEE60A; the Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 44cm Shaft Length, with product code PLEE60A; and the Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter, 34cm shaft length, with product code PSEE60A.
The devices were manufactured between July 18, 2019 and August 3, 2019. According to the FDA, 8,256 devices were distributed throughout the U.S. between August 1, 2019 and September 25, 2019.
Ethicon recommends customers examine their inventory for the affected surgical staplers, quarantine and remove any recalled items found and return any unused units to Ethicon immediately. Those who need proper labels to return the recalled staplers can call Stericycle at 1-866-918-8756 and reference Event #7148. Customers with questions can contact Ethicon Customer Support at 1-877-384-4266.
Surgical Stapler Problems
This latest recall comes amid an ongoing FDA campaign to make surgical staplers safer for patients.
In April, the FDA proposed new rules and guidelines designed to make surgical staplers safer, and decided to classify the products as moderate risk medical devices, as opposed to low-risk devices, which require less oversight.
The new classification would require more stringent premarket approval for new surgical staple guns and force manufacturers to provide more thorough safety warnings and instructions.
The most commonly reported surgical stapler problems involve an opening of the staple line, malformation of staples, staplers misfiring, staplers being too difficult to fire, staplers failing to fire and staplers that were misapplied. The FDA warns that stapler malfunctions or misuse can cause prolonged surgical procedures, the need for additional surgeries, and other complications; such as bleeding, sepsis, internal organ damage, and death.
Ethicon faces a growing number of surgical stapler lawsuits filed in recent months, following prior recalls and problems reported by patients and surgeons nationwide.