BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3242907 · Received July 19, 2013

    Report

    Report Number
    2937094-2013-00787
    Event Type
    Injury
    Date Received
    July 19, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SIDE-FIRING SURGICAL FIBER USING A PROSTATE PROCEDURE, THE OUTPUT BEAM BEGAN TO FLASH, THEN FORWARD FIRING WAS OBSERVED AT 17,327 JOULES OF USE. THE FIBER WAS REPLACED, HOWEVER, WAS NOT RECOGNIZED BY THE LASER SYSTEM DUE TO MISSING GOLD CONTACTS IN THE FIBER'S CONNECTOR. THE CASE WAS COMPLETED USING AN ALTERNATE PROCEDURE (TURP). THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339152 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 313A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other