BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1883186 · Received October 26, 2010

    Report

    Report Number
    3005075853-2010-06090
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    August 6, 2010
    Report Date
    September 14, 2010
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACCOUNT WILL NOT ALLOW ANY INSERVICE. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH JAWS IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS; TWO MALFORMED CLIPS WERE RELEASED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT 12TH FIRING SEQUENCE THUS, IT OVER TRAVELED. THIS FINDING IS NOT RELATED WITH THE EVENT REPORTED. 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 GENERAL SURGERY PROCEDURE THE DEVICE JAMMED AND WOULD NOT FIRE. THERE WAS LITTLE INFORMATION PROVIDED. 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. NA G4PATT

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR