BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1882831 · Received October 26, 2010

    Report

    Report Number
    3005075853-2010-06080
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH ONE PEAR SHAPED CLIP AND WITH THREE J SHAPED CLIPS. THE JAWS WERE INSPECTED AND NO BURR WAS FOUND. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE RECEIVED MALFORMED CLIPS. 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 THREE CLIPS AS INTENDED. HOWEVER, DURING EACH FIRING SEQUENCE THE JAWS REMAINED IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES NOTED. IT SHOULD BE NOTED THAT AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE OF THE OPENING ISSUES. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4)

    Description of Event or Problem · 1

    CALLER INDICATED THE ASSURE 4 METER WAS READING HIGH. AT AROUND 6 PM, NURSE TOOK BG OF PT. THE METER CAME BACK WITH A READING OF 500. THEY FELT THIS WAS TOO HIGH SINCE THE PT FELT FINE. THEY RETESTED WITH ANOTHER METER AND THE BG WAS 89MG/DL. NO TREATMENT GIVEN. CONTROL SOLUTION TESTS WERE WITHIN RANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AS LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE SURGEON FIRED THE DEVICE AND THE CLIP APPLIER JAMMED AND WOULD NOT FIRE. WHEN THE SURGEON OBSERVED THE CLIPS THEY WERE OPEN ENDED AND MALFORMED. THEY COMPLETED THE PROCEDURE WITH A NEW LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1