On May 15, 2019, the FDA issued a Class 1 Recall for a pair of surgical stapler devices manufactured by Ethicon, Inc. (a subsidiary of Johnson & Johnson), for various defects which can increase the risk of severe injury or even death to patients undergoing treatment with the products. The FDA describes that Class I Recalls are reserved for “situations in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”.
This recall involves a total of 92,496 Endo-Surgery Curved and Endo-Surgery Endoscopic Curved Intraluminal Staplers with adjustable height staples that are designed to permit a proper matching of the staples to the diameter of the lumen in gastrointestinal surgeries. The following product codes are involved in this Class 1 Recall: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A and ECS33A. The surgical staplers were manufactured between March 6, 2018 and March 6, 2019, and distributed between March 15, 2018 and March 8, 2019.
Ethicon Endo-Surgery Endoscopic Staplers were designed for use in the gastrointestinal tract to create connections between the sutures in surgical procedures. Some of the most common surgeries in which the Ethicon Stapler were used are:
Potential risks from misfired staplers include:
The recalled staplers were found to have uncut washers and malformed staples due to insufficient firing. Failure to cut the washer indicates a complete 360-degree staple line failure which can compromise staple line integrity. An investigation into Ethicon’s manufacturing process revealed a shift that occurred between March 2018 and March 2019, at which time the manufacturing line was shut down. The FDA warned that use of these intraluminal circular staplers could lead to serious patient harm or death. Ethicon confirmed that misfiring of the stapler was responsible for serious injuries to two patients.