BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 3896586 · Received June 26, 2014

    Report

    Report Number
    3005075853-2014-04423
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = ANTI-BACKUP. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, 6 CONFORMING AND 1 PARTIALLY FORMED CLIP WERE FED DUE TO THE ANTIBACKUP FEATURE WAS NON-FUNCTIONAL AND THEN, IT LOCKED OUT AS INTENDED, HOWEVER, THE ORANGE INDICATOR WAS NOTED UNDER TRAVELED. PLEASE NOTE THAT THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE CONDITION OF THE ANTIBACKUP FEATURE. 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 LAP CHOLECYSTECTOMY, CLIPS FED INTO THE JAWS AT A TIME AFTER SEVERAL FIRINGS. IT WAS UNKNOWN WHICH FIRING OF THE DEVICE THIS EVENT OCCURRED ON. THE DEVICE WAS USED ON THE BLOOD VESSEL. THE DEVICE DID NOT CLAMP SOMETHING HARD SUCH AS AN EXISTING CLIP. THERE WAS NO UNEXPECTED NOISE. AFTER THE EVENT, THE DEVICE WAS FIRED SEVERAL TIMES OUT OF THE PATIENT AND THE SAME EVENT WAS RECREATED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373358 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA L4E96F

    Patients

    Seq Age Sex Outcome Treatment
    1