BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM LARGE TITANIUM LIGA

    MDR report key: 1182744 · Received October 3, 2008

    Report

    Report Number
    1527736-2008-03764
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 29, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 06/17/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THE JAWS DID NOT PROPERLY CLOSE, THUS COME CLIPS FELL OUT CLOSED ONLY IN THEIR DISTAL PART AND SOME FELL DOWN FROM THE DEVICE MISALIGNED AND CROSSED. THE HEMOSTASIS WAS CONTROLLED BY USING ELECTRIC KNIFE. NO ADVERSE PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM LARGE TITANIUM LIGA NONE GDO ETHICON ENDO SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1