BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2974231 · Received February 19, 2013

    Report

    Report Number
    2937094-2013-00246
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 17, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER AND CAP REFER TO THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER'S GLASS CAP WAS FOUND TO BE DETACHED; THE FIBER BROKEN PROXIMAL TO THE FIBER/CAP FUSION ZONE; THE GLASS CAP WAS NOT RETURNED BY THE CUSTOMER. THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. THE IDENTIFIED ISSUES COULD RESULT IN A FORWARD FIRING CONDITION 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 AT 98,288 JOULES, WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, DAMAGE WAS OBSERVED AT THE FIBER TIP. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72370 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 240A

    Patients

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