BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 4890839 · Received July 1, 2015

    Report

    Report Number
    1222895-2015-00027
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Report Date
    June 8, 2015
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FCW
    PMA / PMN Number
    K081477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 9/25/15 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - COULD NOT CONFIRM FAILURE AS UNIT IGNITED AND PASSED LIGHT OUTPUT WITHOUT SMOKING. ADDITIONALLY, THE CONTROL BOARD FAIL SEQUENCING ERROR AND A MOUNTING CLIP WAS MISSING FROM THE TOP COVER. PLUS, POWER ENTRY MODULE AND ATTENUATOR REQUIRE REPLACING. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. (B)(4). HEALTH HAZARD EVALUATION HISTORY: NONE. REPAIR HISTORY: NOT AVAILABLE. CONCLUSION: ROOT CAUSE OF FAILURE CANNOT BE CONCLUSIVELY DETERMINED SINCE THE UNIT POWERED UP AND PASSED LIGHT OUTPUT. ACCORDING TO TECHNICIAN, THE MIRROR WAS NOT INSTALLED INTO THE BRACKET, THIS POTENTIALLY COULD CAUSE THE UNIT TO SMOKE AS IT WOULD MIS-DIRECT THE HIGH INTENSITY LIGHT AND CAUSE THE UNIT TO SMOKE FROM MELTING OR BURNING OF PARTS. NO COMPONENTS APPEARED TO BE BURNT. ADDITIONAL CHECKS SHOWED THE CONTROL BOARD FAILED ERROR SEQUENCING CODES, THE POWER ENTRY MODULE AND ATTENTUATOR SWITCH REQUIRE REPLACING. PLUS, THE TOP COVER IS MISSING AND FASTENING HOOK.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS LIGHTSOURCE WAS SMOKING DURING IN-SERVICE. ON 6/16/15 NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429606 MLX 300W XENON LIGHTSOURCE NA FCW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1