BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3022622 · Received January 4, 2013

    Report

    Report Number
    2937094-2013-00352
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    AMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER'S GLASS CAPS WAS FOUND TO BE DETACHED; THE METAL CAP SHOWED SIGNS OF DETRITUS AND OVERHEATING. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. 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 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 A SIDE-FIRING SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER CAP WAS DAMAGED; THE CASE WAS CONTINUED USING A SECOND FIBER, WHICH STOPPED WORKING AFTER 12 MINUTES OF USE. THE SURGEON COMPLETED THE CASE BY TURP. THERE WAS NO INJURY REPORTED. THIS REPORT IS FOR THE SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6195 GREENLIGHT MOXY FIBER OPTIC POWER SURGICAL LASER INSTRUMENT GEX AMS 10-2400 227A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other