BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2041874 · Received April 6, 2011

    Report

    Report Number
    3005075853-2011-01362
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Report Date
    January 26, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FEEDER SHOE. ADDITIONAL INFORMATION WAS REQUESTED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE ONE JAW AND CAM RAMP DISENGAGED. THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE IN ORDER TO BE REMOVED FROM THE TROCAR AND FORM THE CLIPS. POSSIBLE CAUSES FOR THIS CONDITION MAY BE INADVERTENT FORCE, TWISTING OR PRESSURE BEING PLACED ON THE DEVICE JAWS, USING THE JAWS OF THE DEVICE AS A DISSECTOR/RETRACTOR OR DAMAGE TO THE JAWS WHILE ENTERING THE TROCAR. UPON CYCLING OF THE DEVICE, NO CLIPS WERE FED. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, THE FEEDER SHOE TANG WAS FOUND TO BE BENT AND THREE POCKETS OF THE FEED BAR WERE FOUND TO BE OVER RIDE, CAUSING THE FEEDING ISSUE. POSSIBLE CAUSES FOR THIS CONDITION MAY BE ACCUMULATION OF DRIED BLOOD OR TISSUE IN THE TRACK OR ACTUATING THE TRIGGER WHILE THE JAWS ARE CLOSED IN A TROCAR OR MOLDED END CAP. THIS COULD ALSO RESULT IF THE TIPS ARE BURIED IN TISSUE WHEN ACTUATION OF THE TRIGGER OCCURS. IT SHOULD BE NOTED, THAT THE JAWS NEED TO BE FULLY OPEN IN ORDER FOR THE NEXT CLIP TO BE PROPERLY FED. 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 WAS NOT FEEDING THE CLIPS PROPERLY. THEY WOULD FIRE INTERMITTENTLY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT. NO OTHER DETAILS OF THE EVENT ARE KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1