BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2993071 · Received March 1, 2013

    Report

    Report Number
    2937094-2013-00289
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 7, 2013
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FOR FIBER AND CAP REFER TO THE RESULTS CODE FOR THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER 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. BURNT ON THE DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW WAS ALSO OBSERVED. 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 CAUSE FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, A DECREASE IN TISSUE VAPORIZATION EFFICIENCY WAS OBSERVED AT 14,361 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89430 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMS INNOVATIVE CENTER-SAN JOSE 10-2400 240A

    Patients

    Seq Age Sex Outcome Treatment
    1