BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1832306 · Received September 13, 2010

    Report

    Report Number
    3005075853-2010-05202
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    December 3, 2009
    Report Date
    December 21, 2009
    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
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCER BYPASS THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. THE TIP OF THE ADVANCER SLID TOWARD THE TISSUE STOP DURING TWO CONSECUTIVE FIRING SEQUENCES, CAUSING THE JAWS TO REMAIN IN THE CLOSED POSITION. THE TRIGGER WAS MANUALLY ASSISTED IN ORDER TO OPEN THE JAWS WITHOUT ANY DIFFICULTIES; PEAR SHAPED CLIPS WERE RELEASED. DURING THE NEXT FIRING SEQUENCE A DOUBLE FED INCIDENT WAS NOTED CAUSING PEAR SHAPED CLIPS; HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THIS CONDITION. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS NOT VISIBLE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A LAP CHOLECYSTECTOMY PROCEDURE, THE CLIP WOULD NOT LOAD DURING THE FIRING SEQUENCE. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA F4PL8W

    Patients

    Seq Age Sex Outcome Treatment
    1