BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3042935 · Received March 6, 2013

    Report

    Report Number
    2937094-2013-00319
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIBER ANALYSIS: THE TIP OF THE FIBERS GLASS CAP WAS FOUND TO BE DETACHED, THE FIBER BROKEN PROXIMAL TO THE FIBER/CAP GLUE ZONE; THE FIBER PROXIMAL TO FRACTURE, WAS FOUND TO ROTATE INDEPENDENTLY OF METAL CAP. BURNT ON DETRITUS OF THE METAL CAP AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW WAS ALSO OBSERVED. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PATIENT. THE FIBER/CAP CONDITION COULD RESULT IN A FORWARD-FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE 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, DECREASED TISSUE VAPORIZATION EFFICIENCY WAS OBSERVED AT 59,346 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
    96457 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 241A

    Patients

    Seq Age Sex Outcome Treatment
    1