BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS MOXY FIBER OPTIC

    MDR report key: 3062825 · Received April 12, 2013

    Report

    Report Number
    2937094-2013-00446
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A REQUEST HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIBER FIRED STRAIGHT AFTER 150,000J. THE PROCEDURE WAS FINISHED WITH TURP. NO DAMAGE TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157407 GREENLIGHT XPS MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 307B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other