BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1182826 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03728
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 29, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/16/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A CHOLECYSTECTOMY PROCEDURE, THE JAW DID NOT OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADVERSE CONSEQUENCES TO THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER NONE FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1