BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 1900786 · Received November 16, 2010

    Report

    Report Number
    3005075853-2010-06565
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY, IT WAS NOTED TO BE EMPTY, LOCKED OUT AND WITH THE ORANGE INDICATOR OVER TRAVELED. NO FUNCTIONAL TEST COULD BE PERFORMED TO EVALUATE THE EVENT REPORTED DUE TO THE CONDITION OF THE DEVICE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON CLAMPED THE DEVICE ON THE ARTERY AND IT WOULD NOT UNCLAMP AND TORE THE ARTERY. THERE WAS JUST A LITTLE BLOOD LOSS THAT WAS CONTROLLED WITH ANOTHER CLIP. ANOTHER APPLIER WAS USED TO REPAIR THE TEAR AND TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TX9L

    Patients

    Seq Age Sex Outcome Treatment
    1