BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2222915 · Received August 10, 2011

    Report

    Report Number
    2937094-2011-01636
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 14, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THERE WAS DIMINISHED FIBER VAPORIZATION AT 70,476 JOULES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA 111A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other