BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2941239 · Received January 18, 2013

    Report

    Report Number
    2937094-2013-00107
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    October 22, 2012
    Report Date
    October 29, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 DISTAL TO THE FIBER/CAP FUSION ZONE. THE METAL CAP WAS ALSO FOUND TO HAVE BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW. 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 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

    IT WAS REPORTED THAT DURING THE PROCEDURE, EXCESSIVE FIBERLIFE ACTIVITY OCCURRED. THE CASE WAS COMPLETED WITH A SECOND FIBER. "NO INJURY TO PATIENT REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28310 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 217A

    Patients

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