BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 1933027 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07259
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Report Date
    October 26, 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
    TX, 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; PEAR SHAPE CLIPS WERE RELEASED. DURING THE NEXT FIRING SEQUENCE, THE CLIP WAS FORMED AS CONFORMING. THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS OVER TRAVELED. 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 MISFIRED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO OTHER DETAILS OF THE EVENT ARE KNOWN. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA G4TU9P

    Patients

    Seq Age Sex Outcome Treatment
    1