BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1840945 · Received September 22, 2010

    Report

    Report Number
    3005075853-2010-05460
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 31, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCER BYPASS. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY TO EVALUATE ANY OPENING ISSUES. UPON FIRING OF THE DEVICE, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP DURING FIVE CONSECUTIVE FIRING SEQUENCES CAUSING THAT THE JAWS REMAINED Y THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES; PEAR SHAPED CLIPS WERE RELEASED. IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE ADVANCER BYPASS ISSUES. THE REMAINING TWO CLIPS WERE WITH GAP AND THEN, 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, THE DEVICE WAS FIRED ACROSS THE CYSTIC DUCT WHEN THE JAWS LOCKED SHUT AND WOULD NOT OPEN. THE SURGEON RIPPED THE DEVICE OFF THE TISSUE AND THREW AN ENDOLOOP OVER THE DUCT TO REPAIR THE TORN VESSEL. THERE WAS NO BLOOD LOSS. AN ENDOLOOP WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    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