BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3061571 · Received April 11, 2013

    Report

    Report Number
    2937094-2013-00429
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 15, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER'S METAL AND GLASS CAPS WERE FOUND TO BE DETACHED; THE FIBER BROKEN DISTAL 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 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 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 DURING A PROSTATE PROCEDURE, FOUR SURGICAL FIBERS WERE REPLACED DUE TO REPEATED ACTIVATION OF THE SYSTEMS FIBERLIFE FUNCTION: FIBER NUMBER 1 WAS REPLACED AT 53,083 JOULES OF USE, FIBER NUMBER 2 WAS REPLACED AT 53,625 JOULES OF USE, FIBER NUMBER 3 WAS REPLACED AT 47,089 JOULES OF USE, FIBER NUMBER 4 WAS REPLACED AT 129,468 JOULES OF USE. THE CASE WAS COMPLETED USING A 5TH FIBER. THERE WAS NO INJURY REPORTED. THIS REPORT IS FOR THE THIRD FIBER USED (FIBER NUMBER 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156999 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 238A

    Patients

    Seq Age Sex Outcome Treatment
    1