BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3130070 · Received May 20, 2013

    Report

    Report Number
    2937094-2013-00596
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - REFER TO THE RESULTS CODE 642 THERMAL PROBLEM. FIBER ANALYSIS: A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP WAS FOUND, PROXIMAL TO THE FIBER/CAP FUSION ZONE; THE GLASS CAP/FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. BURNT ON DETRITUS AND DEVITRIFICATION OF THE GLASS CAP OUTPUT WINDOW WAS ALSO OBSERVED. THE IDENTIFIED ISSUES MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM AND DECREASED TISSUE VAPORIZATION EFFICIENCY, OR THE SYSTEM WOULD BE PLACED INTO STANDBY MODE. THE CIRCUMFERENTIAL FRACTURE MAY ALSO CAUSE FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION/USER HANDLING DUE TO TISSUE CONTACT AND OR TECHNIQUE AND ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, LIMITING THE PERFORMANCE OF THE FIBER.

    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 79,736 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223342 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 250A

    Patients

    Seq Age Sex Outcome Treatment
    1