BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2498505 · Received March 15, 2012

    Report

    Report Number
    2937094-2012-00312
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    March 30, 2011
    Report Date
    March 30, 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
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMERS INITIAL REPORT INDICATED A DECREASE IN FIBER VAPORIZATION IS NOT CONSIDERED A REPORTABLE ISSUE HOWEVER, UPON ANALYSIS OF THE RETURNED FIBER, THIS EVENT IS BEING REPORTED. ANALYSIS OF THE RETURNED FIBER FOUND A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP, DISTAL TO THE FIBER/CAP FUSION ZONE. BASED ON THE ANALYSIS FINDINGS, THE FIBER CONDITION COULD 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. (B)(4). THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DECREASE IN FIBER VAPORIZATION EFFICIENCY AT 50,062 JOULES OF USE. 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 107A

    Patients

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