BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 4243633 · Received November 11, 2014

    Report

    Report Number
    3005075853-2014-07824
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE CLIPS WERE MALFORMED AND SCISSORED. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED PARTIALLY CYCLED WITH THE JAWS CLOSED; THE CYCLE WAS COMPLETED IN ORDER TO PERFORM FUNCTIONAL TESTING AND ONE CONFORMING CLIP FELL OFF FROM THE JAWS AND ONE J-SHAPED CLIP WAS FOUND TO BE JAMMED INSIDE THE JAWS. THE J-SHAPED CLIP WAS REMOVED IN ORDER TO PERFORM FUNCTIONAL TESTING; UPON VISUAL INSPECTION, A BURR WAS NOTED TO BE PRESENT AT THE JAWS AND CAM INTERFACE. IN THE NEXT ACTUATIONS OF THE DEVICE, TWELVE CONFORMING CLIPS WERE FED AND FORMED AND THE INSTRUMENT LOCKED OUT AS INTENDED; DURING THE ANALYSIS, THE JAWS OPENED AND CLOSED WITHOUT ANY DIFFICULTIES. NO CONCLUSION COULD BE REACHED AS WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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 MISFIRED. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727124 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1