BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2479662 · Received February 27, 2012

    Report

    Report Number
    2937094-2012-00227
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    February 15, 2011
    Report Date
    February 16, 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
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY REPORTED AS "LASER CONTINUED TO GO INTO STAND-BY MODE" THE ISSUE WAS NOT CONSIDERED A REPORTABLE EVENT. UPON RETURN OF THE FIBER TO THE MANUFACTURER AND FAILURE ANALYSIS, IT WAS FOUND THAT THE FIBER CAP WAS BROKEN OFF; ANALYSIS OF THE CAP FOUND MELTED AND BURNT GLUE/ADHESIVE, ALLOWING THE FIBER AND GLASS CAP TO ROTATE INDEPENDENTLY OF THE STAINLESS STEEL CAP. BASED ON THE ANALYSIS FINDINGS, THE FIBER CONDITION COULD POTENTIALLY RESULT IN A FORWARD FIRING CONDITION AND 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE LASER CONTINUED TO GO INTO STAND-BY MODE. THE CUSTOMER DISCONNECTED THE FIBER AND CONNECTED A SECOND FIBER; THE CASE WAS SUCCESSFULLY COMPLETED AND NO INJURY REPORTED.

    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 052A

    Patients

    Seq Age Sex Outcome Treatment
    1