BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2883076 · Received December 18, 2012

    Report

    Report Number
    2937094-2012-01305
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FIBER CAP DETACHMENT DURING A PROSTATE PROCEDURE COULD RESULT IN A FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 91,081 JOULES OF USE DURING A PROSTATE PROCEDURE, THE MIRROR (CAP) ON FIBER DETACHED INSIDE OF PT AND WAS FLUSHED OUT. THE CASE WAS COMPLETED USING A SECOND FIBER W/O FURTHER ISSUE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 239A

    Patients

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