BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 726455 · Received June 13, 2006

    Report

    Report Number
    1527736-2006-02691
    Event Type
    Malfunction
    Date Received
    June 13, 2006
    Date of Event
    May 21, 2006
    Report Date
    May 22, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    FZP
    PMA / PMN Number
    k050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H4: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 510(K) NUMBER IS K050344.

    Description of Event or Problem · 1

    DURING A LAP CHOLECYSTECTOMY PROCEDURE THE DEVICE JAMMED, UNK WHAT FIRING SEQUENCE. A PIECE FROM THE MECHANISM FELL INTO THE PT. THE PIECE WAS RETRIEVED. UNK WHAT PIECE WAS BROKEN, OR IF THE DEVICE WAS UNDER ANY TYPE OF STRESS. UNK HOW THE CASE WAS COMPLETED. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP FZP ETHICON ENDO SURGERY, INC. NA C4DN6T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN