FDA EIR - Ethicon Endo-Surgery Inc - May 26, 2017

Ethicon Endo-Surgery Inc., located in Blue Ash, OH, underwent a targeted FDA inspection from May 22 to May 26, 2017. This was a limited, directed follow-up inspection focusing on a consumer complaint, along with the company's complaint handling procedures, Medical Device Reports (MDRs), and their integration into the Corrective and Preventive Action (CAPA) system, in accordance with regulatory guidelines for medical device manufacturers. Although no formal FDA Form 483, "Inspectional Observations," was issued, the inspection concluded with three significant discussion items for the company to address. Firstly, concerns were raised regarding the adequacy of investigations into adverse trends, specifically for "Jaw Cutting" incidents involving the MCS20 product. The existing CAPA plan addressing related issues did not explicitly cover "Jaw Cutting," and documentation for investigating other root causes was found to be insufficient. Secondly, the firm's "Complaint Category and Risk Management Procedure" was noted for its potentially circular nature concerning risk assessment and the addition of new complaint codes, raising questions about the consistent assignment of risk and reportability. Missing signatures on several related change request forms were also identified. Lastly, the inspection highlighted insufficient investigation depth, particularly the lack of device disassembly for certain returned products, even when device malfunction was suspected. There were also instances of inaccurate data marking in complaint records, which could lead to skewed analysis. Company management acknowledged these observations and committed to addressing them with the same seriousness as if a formal FDA 483 had been issued, indicating a commitment to internal corrective measures.