BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3252564 · Received July 25, 2013

    Report

    Report Number
    2937094-2013-00822
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 24, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    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. THE METAL CAP EXHIBITED DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW WAS ALSO OBSERVED. THE IDENTIFIED ISSUES MAY ACTIVATE THE LASER SYSTEM FIBERLIFE FUNCTION WHICH WILL MODULATE THE POWER SHOWING A PULSING BEAM OR THE SYSTEM WILL REVERT TO STANDBY MODE. THE CIRCUMFERENTIAL FRACTURE ISSUE MAY ALSO RESULT IN A FORWARD-FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE ISSUE WAS DETERMINED TO BE LOCALIZED HEAT ACCUMULATION/ USER HANDLING, DUE TO ANATOMICAL/ PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 13,305 JOULES WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER CARD CEASED TO PERMIT FIBER FUNCTION. THE FIBER WAS REPLACED AND THE CASE COMPLETED USING A SECOND FIBER. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347715 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 234A

    Patients

    Seq Age Sex Outcome Treatment
    1