BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 3894519 · Received June 25, 2014

    Report

    Report Number
    3005075853-2014-04380
    Event Type
    Malfunction
    Date Received
    June 25, 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
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BENT ADVANCER. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: PLEASE CLARIFY THE TRIGGER WAS STUCK: IT WORKED FOR TWO TIMES AND THEN IT STARTED TO GET STUCK. WAS THE TRIGGER STUCK OPEN AND WOULD NOT CLOSE? IT WAS STUCK OPEN AND WOULD NOT CLOSE. WAS THE TRIGGER STUCK CLOSED AND WOULD NOT OPEN? NO, AS PER THE ABOVE ANSWER. WERE THE JAWS OF THE DEVICE ON TISSUE? NO THEY WEREN¿T, THE MALFUNCTION WAS DETECTED OUTSIDE. IF SO HOW WAS THE DEVICE REMOVED FROM THE TISSUE? NA. AT WHAT FIRING DID THE ISSUE OCCUR? AT THE THIRD FIRING. THE ANALYSIS RESULTS FOUND THAT ONE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE EVENT REPORTED, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS FIRED AND THE CLIPS DID NOT FULLY ADVANCE INTO THE JAW. THE DEVICE WAS NOTED TO HAVE THE TIP OF THE ADVANCER BENT TOWARD TISSUE STOP AND BACKWARDS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE DAMAGE FOUND. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 MINIMALLY INVASIVE CABG PROCEDURE AS FIRING THE LIGACLIP APPLIER THE TRIGGER WAS STUCK AND NO CLIP WERE DEPLOYED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372083 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1