BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1844223 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00258
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    AMS INNOVATION CENTER-SILICONE VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER FORWARD FIRED. THE CUSTOMER STATED THAT THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 85,784 JOULES. NO PT INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED TO AMERICAN MEDICAL SYSTEMS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS INNOVATION CENTER-SILICONE VALLEY NA 011H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other