BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2941240 · Received January 18, 2013

    Report

    Report Number
    2937094-2013-00106
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    October 18, 2012
    Report Date
    October 24, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    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 GLASS CAP DISTAL TO THE FIBER/CAP FUSION ZONE. THE METAL CAP HAS BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW. BOTH CAPS ATTACHED. SEVERE OVERHEATING NOTED AT THE FIBER CAP OPEN END; FIBER HAS BEEN FRACTURED PROXIMAL TO FIBER CAP FUSION ZONE. CONTAMINATION NOTED IN OUTER FLOW TUBE NEAR PROXIMAL FRACTURE. THE IDENTIFIED ISSUES NOTED ABOVE MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR SYSTEM WOULD BE PLACED INTO STANDBY MODE. THE POTENTIAL FOR FORWARD FIRING MAY EXIST. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE RELATED TO LOCALIZED HEAT ACCUMULATION/USER HANDLING DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS DECREASED VAPORIZATION AT 100,692 JOULES. THE CASE WAS COMPLETED WITH A SECOND FIBER. NO INJURY TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28515 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 225A

    Patients

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