BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1840199 · Received September 21, 2010

    Report

    Report Number
    3005075853-2010-05411
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 28, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FEEDER SHOE DAMAGED WITH CLIP PRESENT IN DEVICE. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON ACTIVATION OF THE TRIGGER, THE CLIPS COULD NOT BE FED INTO THE JAWS. IN ORDER TO EVALUATE THE DEVICE'S INTERNAL COMPONENTS THE DEVICE WAS DISASSEMBLED, UPON DISASSEMBLING OF THE DEVICE THE TAB OF THE FEEDER SHOE THAT INTERACTS WITH THE FEED BAR WAS FOUND TO BE BENT CAUSING THE FOUND FEEDING ISSUES. FIFTEEN CLIPS WERE FOUND ON THE CLIP TRACK. POSSIBLE CAUSE FOR THIS CONDITION MAY BE THE ACTIVATION OF THE TRIGGER WHEN A JAMMING OCCURRED. 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 WAS BROKEN AND THERE WERE NO CLIPS IN THE DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4RZ09

    Patients

    Seq Age Sex Outcome Treatment
    1