BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2974365 · Received February 19, 2013

    Report

    Report Number
    2937094-2013-00247
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 7, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP, DISTAL TO THE FIBER/CAP FUSION ZONE; THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW WAS ALSO OBSERVED. BOTH CAPS REMAIN INTACT AND ATTACHED. THE RETURNED FIBER CARD WAS VERIFIED WITH 133,559 JOULES OF USE; EXPIRATION OF THE FIBER CARD WAS NOT CONFIRMED. 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. THIS ISSUE MAY ALSO CAUSE FORWARD-FIRING. THE IDENTIFIED ISSUES MAY ACTIVATE THE FIBER LIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR THE SYSTEM WOULD REPLACED INTO STANDBY MODE. THIS ISSUE MAY ALSO CAUSE FORWARD-FIRING. THE MOST PROBABLE ROOT CAUSE OF THE DEVIC FAILURE AS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE SURGICAL FIBER TIME EXPIRED AT 133,559 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72505 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 239A

    Patients

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