BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1914916 · Received November 17, 2010

    Report

    Report Number
    2937094-2010-01088
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 21, 2010
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 AND/OR THE TIP OF THE FIBER WAS DAMAGED AT 148,321 JOULES. ALSO, IT WAS REPORTED THAT THERE WAS A DECREASE IN VAPORIZATION EFFICIENCY. NO PT INJURY WAS REPORTED. A DEVICE EVAL IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 037A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other