BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2498506 · Received March 15, 2012

    Report

    Report Number
    2937094-2012-00311
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    March 15, 2011
    Report Date
    March 15, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMERS INITIAL REPORT INDICATED DIMINISHED VAPORIZATION EFFICIENCY, WHICH IS NOT CONSIDERED A REPORTABLE ISSUE HOWEVER, UPON ANALYSIS OF THE RETURNED FIBER, THIS EVENT IS BEING REPORTED. ANALYSIS OF THE RETURNED FIBER FOUND THE FIBER CAP TO BE DETACHED; THE FIBER BROKEN PROXIMAL TO THE FIBER/CAP FUSION ZONE. THE FIBER CAP WAS NOT RETURNED. THE FIBER CONDITION COULD RESULT IN A FORWARD FIRING CONDITION, WHICH HAS BEEN IDENTIFIED AS A POTENTIAL SAFETY ISSUE. NO INJURY WAS REPORTED AS A RESULT OF THIS EVENT. 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. 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 SIGNIFICANTLY DIMINISHED VAPORIZATION EFFICIENCY AT 183,370 JOULES OF USE. A SECOND FIBER WAS USED TO COMPLETE THE CASE. 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 NA 105A

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT SURGICAL LASER SYSTEM & ACCESSORIES