BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2915201 · Received January 9, 2013

    Report

    Report Number
    2937094-2013-00044
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    January 13, 2012
    Report Date
    January 16, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULT CODE THERMAL PROBLEM. ANALYSIS: THE FIBER WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP, PROXIMAL TO THE FIBER/CAP FUSION ZONE; THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. THIS ISSUE COULD PRODUCE DEFUSE REFLECTIONS OF EMITTED LIGHT WHICH MIGHT APPEAR AS LIGHT BEING EMITTED UPWARD AS REPORTED. BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW WAS ALSO OBSERVED. THE FIBER CONDITION WOULD LIKELY RESULT IN ACTIVATION OF THE SYSTEM'S FIBERLIFE FUNCTION WHICH WILL MODULATE (PULSE) THE OUTPUT BEAM, RESULTING IN REDUCED TISSUE VAPORIZATION EFFICIENCY AND/OR SEND THE SYSTEM TO STANDBY MODE. THE FIBER/CAP CONDITION COULD ALSO RESULT IN FORWARD FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND/OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, RESULTING IN FIBER BREAKAGE AND CAP DAMAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO VAPORIZATION EFFECT AT 7,638 JOULES OF USE DURING A PROSTATE PROCEDURE. THE CUSTOMER ALSO REPORTED THAT THE BEAM FIRED UP TOWARDS THE BLUE ALIGNMENT INDICATOR RATHER THAN DOWN. THE CASE WAS COMPLETED TURP. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12718 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 123A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| GREENLIGHT XPS LASER SYSTEM