BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3223477 · Received July 9, 2013

    Report

    Report Number
    2937094-2013-00738
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE "FIBER CAP DETACHMENT WHILE INSIDE OF THE PT. ALL PIECES RETRIEVED". CASE WAS COMPLETED WITH A SECOND FIBER. THE OUTCOME WAS REPORTED AS "NO PT INJURY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312368 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 314A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other