BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON LIGAMX 5MM ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 2090722 · Received May 12, 2011

    Report

    Report Number
    2090722
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ETHICON ENDOSCOPIC CLIP APPLIER EL5ML, LOT # H4390Y USED FOR CLIPPING THE CYSTIC DUCT ON A LAP CHOLECYSTECTOMY CASE MALFUNCTIONED. CLIPS DID NOT CLOSE PROPERLY AND WOULD FALL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON LIGAMX 5MM ENDOSCOPIC MULTIPLE CLIP APPLIER CLIP APPLIER FZP ETHICON ENDO SURGERY EL5ML H4390Y

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR