BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2090752 · Received April 26, 2011

    Report

    Report Number
    2937094-2011-00819
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AMS INNOVATIVE CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 99,133 JOULES. ALSO, IT WAS REPORTED THE FIBER LIFE CONTINUED TO ACTIVATE, THERE WAS SLOW VAPORIZATION AND THE FIBER END FIRED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS INNOVATIVE CENTER-SILICON VALLEY NA 108A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other