BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2926538 · Received January 17, 2013

    Report

    Report Number
    2937094-2013-00099
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    June 11, 2012
    Report Date
    June 11, 2012
    Manufacturer
    AMERICAN MED SYSTMES
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES: FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER METAL CAP WAS FOUND TO BE DETACHED; THE FIBER BROKEN DISTAL TO THE FIBER/CAP FUSION ZONE; THE METAL AND GLASS CAPS WERE RETURNED BY THE CUSTOMER. THE FIBER'S OUTER FLOW TUBE WAS ALSO FOUND TO BE DAMAGED. 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 THE 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 129,787 JOULES OF USE DURING A PROSTATE PROCEDURE, THE TIP OF THE SURGICAL FIBER OBSERVED TO BE BURNT. THE CASE WAS COMPLETED USING A THIRD FIBER; THE SECOND FIBER WAS DAMAGED PRIOR TO USE WHILE INSERTING INTO THE SCOPE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25340 GREENLIGHT MOXY FIBER OPTIC POWER SURGICAL LASER INSTRUMENT GEX AMERICAN MED SYSTMES 10-2400 216A

    Patients

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