BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2493354 · Received March 12, 2012

    Report

    Report Number
    2937094-2012-00200
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    December 6, 2010
    Report Date
    January 24, 2011
    Manufacturer
    AMS, INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S INITIAL REPORT THAT THE SYS KEPT GOING INTO STANDBY MODE 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 FRACTURED AND PARTIALLY BROKEN WITH 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. THE PRODUCT LABELING WARNS THAT TISSUE CONTACT OR TISSUE PROBING MAY CAUSE FIBER DAMAGE OR BREAKAGE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SYS KEPT GOING INTO STANDBY MODE AT 91,907 JOULES OF USE. THE CASE WAS COMPLETED USING 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 AMS, INNOVATION CENTER-SILICON VALLEY NA 044A

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT SURGICAL LASER SYS| AND ACCESSORIES