BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2537993 · Received April 9, 2012

    Report

    Report Number
    2937094-2012-00372
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE CUSTOMERS INITIAL REPORT THAT THE SYSTEMS FIBERLIFE FUNCTION ACTIVATED NUMEROUS TIMES, IS NOT CONSIDERED A REPORTABLE ISSUE. UPON ANALYSIS OF THE RETURNED FIBER, THE FIBER WAS FOUND TO BE BROKEN PROXIMAL TO THE FIBER/CAP FUSION ZONE. THE CAP WAS ALSO FOUND TO HAVE BURN ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW. THE FIBER CONDITION WOULD RESULT IN ACTIVATION OF THE SYSTEMS FIBERLIFE FUNCTION AND SEND THE SYSTEM TO STANDBY MODE. BASED ON THE ANALYSIS FINDINGS, THE FIBER CONDITION MAY RESULT IN A FORWARD FIRING CONDITION, WHICH HAS BEEN IDENTIFIED AS A POTENTIAL SAFETY ISSUE. 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, RESULTING IN FIBER BREAKAGE AND CAP DAMAGE. THE PRODUCT LABELING WARNS THAT TISSUE CONTACT, TISSUE PROBING AND BENDING OF THE FIBER AT SHARP ANGLES MAY CAUSE FIBER DAMAGE. THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SYSTEM'S FIBERLIFE FUNCTION ACTIVATED NUMEROUS TIMES THROUGHOUT THE PROCEDURE. THE CASE WAS COMPLETED WITH A SECOND FIBER. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY 0010-2400 125A

    Patients

    Seq Age Sex Outcome Treatment
    1