FDA EIR - Ethicon Endo-Surgery Inc - August 15, 2019

An FDA inspection of Ethicon Endo-Surgery Inc. in Blue Ash, OH, was conducted from August 12-15, 2019. This compliance-directed inspection primarily focused on the company’s corrective actions following a voluntary Class I recall (RES #82539) of its Intraluminal Staplers (ILS). The recall was initiated due to an “insufficient firing stroke” issue, leading to uncut washers and malformed staple lines. The inspection, conducted under medical device manufacturing regulations (CPGM 7382.845), reviewed the firm's initiated corrective and preventive actions (CAPA-009015), which included manufacturing process improvements and updates to knife component drawing dimensions. Although no FDA-483 observations were formally issued, discussions with management identified two critical areas for improvement: the apparent lack of a clear procedure for the design verification process related to design changes, and the firm’s justification for not completing design validation for changes deemed undetectable by the customer, which did not align with regulatory intent. Management pledged to address these discussion items to enhance compliance. Information regarding a separate Class II recall for ENSEAL X1 Tissue Sealers was also collected during the inspection.