BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2932326 · Received January 22, 2013

    Report

    Report Number
    2937094-2013-00120
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    May 1, 2012
    Report Date
    May 1, 2012
    Manufacturer
    AMERICAN MED SYS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 WAS BROKEN PROXIMAL TO THE FIBER/CAP FUSION ZONE. THE METAL AND GLASS CAPS WERE RETURNED BY THE CUSTOMER. THE IDENTIFIED ISSUES MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR SYSTEM WOULD BE PLACED INTO STANDBY MODE. THIS ISSUE MAY ALSO CAUSE FORWARD-FIRING. THE 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 EVERY TIME THE FOOT PEDAL WAS DEPRESSED, THE SYS WOULD KICK IT INTO STANDBY MODE, AS IF THE FIBER WERE OVER HEATING. THE CASE WAS COMPLETED USING A SECOND FIBER. PT OUTCOME: "GREAT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31609 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MED SYS 10-2400 210A

    Patients

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