BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER/MOXY LIQUID COOLED FIBER

    MDR report key: 5541486 · Received March 29, 2016

    Report

    Report Number
    MW5061407
    Event Type
    Malfunction
    Date Received
    March 29, 2016
    Date of Event
    March 25, 2016
    Report Date
    March 29, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    AMERICAN MEDICAL SYSTEMS (AMS), MOXY GREENLIGHT LASER FIBER, METALLIC TIP BROKE OFF OF THE FIBER APPROXIMATELY 10 SECONDS AFTER INITIAL USE. THE METALLIC TIP WAS IMMEDIATELY RETRIEVED INTACT BY THE SURGEON, AND A NEW FIBER WAS UTILIZED FOR THE REMAINDER OF THE PROCEDURE. DIAGNOSIS OR REASON FOR USE: LASER VAPORIZATION OF THE PROSTATE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188717 GREENLIGHT MOXY FIBER/MOXY LIQUID COOLED FIBER MOXY LASER FIBER GEX AMERICAN MEDICAL SYSTEMS 10-2400 10-2400-546A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR