BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1844021 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00085
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 31, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 49,600 JOULES. NO INJURY WAS REPORTED. A DEVICE EVALUATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA 944Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Other