BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1053121 · Received May 16, 2008

    Report

    Report Number
    1527736-2008-03115
    Event Type
    Injury
    Date Received
    May 16, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE JAWS WOULD NOT OPEN AND WAS STUCK ON THE BILE DUCT. DEVICE REMOVED BY PULLING IT OFF THE TISSUE RESULTING IN A BILE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER FZP ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4KJ84

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention