BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2537995 · Received April 9, 2012

    Report

    Report Number
    2937094-2012-00371
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    June 27, 2011
    Report Date
    July 25, 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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE CUSTOMER'S INITIAL REPORT THAT THE FIBER FAILED AT START UP IS NOT CONSIDERED A REPORTABLE ISSUE. UPON ANALYSIS OF THE RETURNED FIBER, THE FIBER WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE PROXIMAL TO THE FIBER/CAP FUSION ZONE. THE GLASS CAP WAS ALSO FOUND TO EXHIBIT DEVITRIFICATION. THE FIBER CONDITION WOULD RESULT IN ACTIVATION OF THE SYSTEMS FIBERLIFE FUNCTION AND MODULATE THE OUTPUT BEAM OR 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 OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE FIBER FAILED AT START UP. 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 113A

    Patients

    Seq Age Sex Outcome Treatment
    1