BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2901307 · Received January 2, 2013

    Report

    Report Number
    2937094-2013-00011
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT 79,232 JOULES OF USE DURING A PROSTATE PROCEDURE, THE SIDE-FIRING SURGICAL FIBER WAS OBSERVED TO BE FORWARD FIRING. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 240A

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT XPS LASER SYSTEM| ACCESSORIES