BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM ENDO CLIP APPLIER

    MDR report key: 7234648 · Received February 1, 2018

    Report

    Report Number
    3005075853-2018-07695
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    December 11, 2017
    Report Date
    December 11, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    UDI-DI
    20705036001840
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # P92003. DEVICE ANALYSIS: THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED WITH NO DAMAGE IN THE EXTERNAL COMPONENTS. IN AN ATTEMPT TO REPLICATE THE REPORTED EVENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS FIRED AND THE CLIPS DID NOT ADVANCE INTO THE JAW. THE DEVICE WAS NOTED TO HAVE THE TIP OF THE ADVANCER BENT. THE INSTRUMENT WAS DISASSEMBLED, UPON DISASSEMBLY THE ADVANCER WAS CONFIRMED TO BE BENT AND 5 CLIPS WERE FOUND INSIDE CLIP TRACK. A POSSIBLE CAUSE FOR THE CONDITION OF BENT ADVANCER IS ACTUATING THE DEVICE WHEN THE JAWS ARE NOT CLEAR OF THE TROCAR. ACTUATING THE DEVICE WITH THE JAWS CLOSED MAY BEND THE ADVANCER. PLEASE NOTE THAT PRIOR TO LOADING A CLIP IN THE JAWS, ENSURE THAT THE DEMARCATION BETWEEN THE JAWS AND THE DEVICE SHAFT IS PAST THE END OF THE TROCAR CANNULA. ADDITIONALLY, EXCESSIVELY APPLYING A SIDE LOAD TO THE JAWS, CAUSING THEM TO PARTIALLY COLLAPSE COULD RESULT IN A CLIP MALFORMATION. THE DEVICE JAWS SHOULD BE FULLY OPEN AND PARALLEL UPON INITIATING THE FIRING OF THE DEVICE. 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 HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    DURING THE CASE, THE PRODUCT WAS USED ON VEIN TO APPLY CLIPS, BUT THE DEVICE LOCKED ITSELF DURING FIRST FIRING AND WHEN THE SURGEON TRIED TO FIRE THE DEVICE AGAIN, THE CLIPS CAME ON TOP OF EACH OTHER RESULTING THE DEVICE TO BE UNABLE TO USE. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE: LAP CHOLECYSTECTOMY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77081 LIGAMAX-5MM ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. UNK 20705036001840

    Patients

    Seq Age Sex Outcome Treatment
    1