BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 5841747 · Received August 2, 2016

    Report

    Report Number
    2523190-2016-00122
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Report Date
    July 15, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 9/6/16 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION RESULTS: FAILURE ANALYSIS - IT HAS BEEN CONFIRMED WITH THE CUSTOMER THAT THE MLX 300W XENON LIGHTSOURCE RELATED TO THIS COMPLAINT WILL NOT BE AVAILABLE TO RETURN TO INTEGRA FOR EVALUATION. - INTEGRA LUXTEC MLX 300 WATT XENON LIGHT SOURCE USER MANUAL: PRECAUTIONS (PAGE 5) ¿ TAKE PRECAUTIONS TO VERIFY THAT THE FIBER OPTIC CABLE IS APPROPRIATELY SUITED FOR THE LIGHT SOURCE. XENON AND OTHER HIGH ILLUMINATION LIGHT SOURCES REQUIRE PREMIUM FIBER OPTIC CABLES IN ORDER TO ACHIEVE OPTIMAL PERFORMANCE AND PREVENT DAMAGE TO THE FIBERS, THEREBY DIMINISHING THE QUALITY OF THE LIGHT OUTPUT OR THE USEFUL LIFE OF FIBER OPTIC CABLE. USE ONLY FIBER OPTIC LIGHT GUIDE CABLES WITH THE CORRECT PROXIMAL FITTING FOR YOUR TURRET AND APPROVED AND TESTED FOR COMPATIBILITY WITH HIGH INTENSITY XENON LAMPS OF 300W OR HIGHER. - THE KARL STORZ INFORMATION AND PRODUCT USE GUIDE INDICATES THAT THE 3.5MM CABLES ARE NOT SPECIFIED AS A PERFORMANCE CABLE. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER / MANUFACTURING CHANGE ORDER HISTORY: NONE. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: NOTE THAT THE KARL STORZ FIBER OPTIC CABLE, BIFURCATED IS NOT APPROVED FOR USE WITH THE INTEGRA LUXTEC MLX 300 WATT XENON LIGHT SOURCE.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS NURSES DETECTED A BURNING ODOR SOON AFTER A BIFURCATED KARL STORZ FIBER OPTIC CABLE (3.5MM DIAMETER) WAS CONNECTED TO A MLX LIGHT SOURCE (BIOMED THINKS IT WAS A NEW MLX BUT IS NOT ABSOLUTELY CERTAIN). THE OTHER END OF THE CABLE WAS CONNECTED TO A BENJAMIN-HAVAS LIGHT CLIP. THE BURNING ODOR WAS ASSOCIATED WITH THE END OF THE LIGHT CABLE THAT DIRECTLY CONNECTS WITH THE MLX.. ON 7/27/2016 NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491840 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1