BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3042287 · Received April 1, 2013

    Report

    Report Number
    2937094-2013-00415
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 4, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER IS BROKEN PROXIMAL TO AND UNDER THE METAL CAP; THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. THE GLASS CAP SHOWS DEVITRIFICATION OF THE CAP AT OUTPUT WINDOW. THE METAL CAP SHOWS SIGNS OF BURN AND MILD CHARRING. THE IDENTIFIED ISSUES MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR THE SYSTEM WOULD BE PLACED INTO STANDBY MODE. THE POTENTIAL FOR FORWARD FIRING MAY EXIST. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THE FAILURE IS SUSPECTED TO BE LOCALIZED HEAT ACCUMULATION / USER HANDLING DUE TO ANATOMICAL / PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, DIMINISHED TISSUE VAPORIZATION EFFICIENCY WAS OBSERVED AT 148,000 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. PT OUTCOME: "NO DAMAGES TO THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132845 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 243A

    Patients

    Seq Age Sex Outcome Treatment
    1