BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3101335 · Received May 3, 2013

    Report

    Report Number
    2937094-2013-00523
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 CAP WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP, PROXIMAL TO THE FIBER/CAP FUSION ZONE, THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. THE FIBER WAS FOUND TO BE BENT BETWEEN THE OUTLET FLOW TUBE AND THE METAL CAP. BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW WAS ALSO OBSERVED. BOTH CAPS REMAIN INTACT AND ATTACHED. 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 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 WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER STOPPED WORKING AT 201, 038 JOULES OF USE. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194550 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMS 10-2400 302A

    Patients

    Seq Age Sex Outcome Treatment
    1