BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON 10MM LAPAROSCOPIC ENDOPOUCH

    MDR report key: 17798497 · Received September 21, 2023

    Report

    Report Number
    MW5146016
    Event Type
    Other
    Date Received
    September 21, 2023
    Date of Event
    September 11, 2023
    Report Date
    September 19, 2023
    Manufacturer
    ETHICON, INC.
    Product Code
    GCJ
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A SCHEDULED PROCEDURE, SURGEON ATTEMPTED TO USE THE 10 MM ETHICON LAPAROSCOPIC ENDOPOUCH REF# POUCH. THE ITEM FAILED AND A SECOND WAS BROUGHT TO THE OR(OPERATING ROOM). THE SECOND ONE ALSO FAILED TO OPERATE PROPERLY. EACH HAD THE SAME REF#- THEY BOTH HAD THE LOTS# 514C95 AND EXP 2028-06-30. A THIRD WAS OPENED AND USED. THE PROCEDURE WAS COMPLETED AFTER THE THIRD ITEM FUNCTIONED. REF REPORT: MW5146017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295856 ETHICON 10MM LAPAROSCOPIC ENDOPOUCH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ ETHICON, INC. POUCH 514C95

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown