BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX 5MM

    MDR report key: 3781091 · Received April 30, 2014

    Report

    Report Number
    3005075853-2014-02946
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 12, 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). FEEDER SHOE DAMAGED. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, IT WAS NOTED THAT THE CLIPS DID NOT ADVANCE INTO THE JAW. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, 15 CLIPS WERE FOUND ON CLIP TRACK AND THE FEEDER SHOE TAB WAS NOTED DAMAGED CAUSING THAT IT DID NOT ENGAGE WITH THE FEED BAR WHILE THE FIRING TRIGGER IS SQUEEZING THUS, THE CLIPS COULD NOT BE FEED INTO THE JAWS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THIS CONDITION. PLEASE NOTE THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT 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 AN UNKNOWN PROCEDURE, THE CLIP DID NOT COME OUT AT THE 1ST FIRING THOUGH THE TRIGGER WAS GRASPED SEVERAL TIMES. 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
    260357 LIGAMAX 5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1