BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3202270 · Received June 28, 2013

    Report

    Report Number
    2937094-2013-00713
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 19, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER WAS FOUND TO HAVE A RADIAL FRACTURE AND SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW; THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. THE METAL CAP WAS FOUND TO EXHIBIT CHAR DETRITUS. THE RETURNED FIBER CARD WAS ANALYZED AND FOUND TO BE PROPERLY FUNCTIONED AND VERIFIED TO BE EXPIRED; THE SOFT JOULE LIMIT WAS REACHED AT 170,150 JOULES OF USE. THE IDENTIFIED ISSUES MAY ACTIVATE THE LASER SYSTEMS FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR THE SYSTEM WOULD BE PLACED INTO STANDBY MODE. THE RADIAL FRACTURE 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 THE FIBER CARD WAS NOT RECOGNIZED BY THE LASER SYSTEM AND WOULD NOT PERMIT THE SURGICAL FIBER TO FUNCTION. IT IS NOT KNOWN HOW THE CASE WAS COMPLETED. NO ADDITIONAL INFO WAS PROVIDED. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296173 GREENLIGHT MOXY FIBER OPTIC POWER SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 222A

    Patients

    Seq Age Sex Outcome Treatment
    1