BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1905599 · Received November 23, 2010

    Report

    Report Number
    3005075853-2010-06652
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Report Date
    October 1, 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
    MA, US
    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. UPON FIRING, THE TIP OF THE ADVANCER SLID TOWARD TISSUE STOP DURING THE CONSECUTIVE FIRING SEQUENCES CAUSING THE JAWS REMAINED 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 THE CLIP WAS FORMED AS CONFORMING. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR DID NOT SHOW UP. 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 AN UNKNOWN PROCEDURE THE DEVICE LOCKED OUT AND WOULD NOT FIRE CLIPS. NO OTHER INFORMATION WAS AVAILABLE AT THIS TIME. NO PATIENT CONSEQUENCE WAS REPORTED. THE DEVICE IS RETURNING FOR ANALYSIS.

    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