BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3231728 · Received July 12, 2013

    Report

    Report Number
    2937094-2013-00742
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR #: 2937094-2013-00743.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A SURGICAL FIBER DURING A PROSTATE PROCEDURE, DIMINISHED TISSUE VAPORIZATION WAS OBSERVED AND THE FIBER CAP DETACHED. A SECOND FIBER WAS USED AND REPORTED TO HAVE DIMINISHED TISSUE VAPORIZATION AND CAP DETACHMENT. A THIRD SURGICAL FIBER WAS USED AND THE LASER SYSTEMS FIBERLIFE FUNCTION ACTIVATED; THE SYSTEM WENT INTO STANDBY MODE. THE PROCEDURE WAS COMPLETED USING A FORTH SURGICAL FIBER. THERE WERE NO "DAMAGES TO THE PT". THIS REPORT IS FOR THE FIRST SURGICAL FIBER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322993 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 311A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other