BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS MOXY FIBER OPTIC

    MDR report key: 3150135 · Received May 30, 2013

    Report

    Report Number
    2937094-2013-00644
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE THE CAP DETACHED WHILE INSIDE THE PATIENT. A SECOND FIBER WAS USED TO FINISH THE PROCEDURE. NO INJURY TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238050 GREENLIGHT XPS MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 309B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other