BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2072776 · Received April 29, 2011

    Report

    Report Number
    3005075853-2011-01781
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    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). ADVANCER. ADDITIONAL INFORMATION WAS REQUESTED. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED; ONE PEAR SHAPED CLIP WAS RELEASED. UPON FIRING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED; NO SCISSORED CLIPS WERE NOTED. A POSSIBLE CAUSE FOR THE MALFORMED CLIP MAY BE THAT AN ADVANCER BYPASS HAPPENED. THIS CAN OCCUR WHEN THE TIP OF THE ADVANCER IS ABOVE OR BELOW THE CLIP INSTEAD OF BEING POSITIONED AT THE BACK OF THE CLIP, SINCE THE CLIP IS NOT FULLY ADVANCED IN THE JAWS. THIS WILL PREVENT THE JAWS FROM CLOSING PROPERLY, RESULTING IN A PEAR SHAPED CLIP AND SUBSEQUENTLY THE JAWS MAY REMAIN CLOSED AFTER FIRING, REQUIRING A MANUAL TRIGGER OPENING. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. 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, ON THE FIRST FIRING THE CLIP SCISSORED AND THE DEVICE LOCKED OUT. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1