BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2971376 · Received February 4, 2013

    Report

    Report Number
    2937094-2013-00161
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    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'S METAL AND GLASS CAPS WERE FOUND TO BE DETACHED; THE FIBER BROKEN PROXIMAL TO THE FIBER/CAP FUSION ZONE; THE METAL AND GLASS CAPS WERE NOT RETURNED BY THE CUSTOMER. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PATIENT. THE FIBER/CAP CONDITIONS WOULD RESULT IN FORWARD FIRING. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION/ USER HANDLING 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, DAMAGE TO THE FIBER CAP WAS OBSERVED AT 182,918 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47532 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 229A

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| GREENLIGHT XPS LASER SYSTEM