BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1883913 · Received October 27, 2010

    Report

    Report Number
    3005075853-2010-06109
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DRIED BODILY FLUIDS. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS DIFFICULT TO CYCLE. THE TRIGGER WAS MANIPULATED AND THE DEVICE WHEN FIRED, RELEASED TWO PEAR SHAPED CLIPS; IT COULD NOT FURTHER FEED CLIPS UPON CYCLING OF THE TRIGGER. THE DEVICE WAS DISASSEMBLED AND CLIPS WERE FOUND ADHERED TO THE CLIPS TRACK DUE TO EXCESSIVE DRIED BODY FLUIDS. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION. 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 DEVICE FIRED SCISSORED CLIPS. NO ADVERSE CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED. NO DETAILS ARE AVAILABLE FOR EITHER OF THE DEVICES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1