BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2031442 · Received March 28, 2011

    Report

    Report Number
    3005075853-2011-01211
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE VISUAL INDICATOR WAS OVER-TRAVELED. WHEN THIS OCCURS, THE INDICATOR WHEEL MAY CONTINUE TO ROTATE AFTER INDICATION OF A COMPLETELY FIRED DEVICE. PLEASE NOTE THE OVER-TRAVEL OF THE INDICATOR WHEEL IS NOT RELATED TO THE REPORTED EVENT. 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 FIRING WAS NOT SMOOTH AND THE DEVICE WAS NOT DEPLOYING GOOD CLIPS. THE CLIPS WERE NOT CLOSING OR SCISSORING ON EVERY FIRE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA H4321U

    Patients

    Seq Age Sex Outcome Treatment
    1