BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 6122813 · Received November 22, 2016

    Report

    Report Number
    2523190-2016-00198
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 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

    ON 12/28/16 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION RESULTS: FAILURE ANALYSIS - A VISUAL INSPECTION FOUND NO EXTERNAL VISIBLE. PHYSICAL DAMAGE. THE HEAT EXTENDER MIRROR WAS DISLODGED FROM ITS HOLDER AND LOOSE IN THE UNIT. FUNCTIONAL TESTING FOUND THE LAMP IGNITED AND FUNCTIONED PROPERLY. 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: THERE WAS NO ADDITIONAL, PHYSICAL DAMAGE. FUNCTIONAL TESTING FOUND THE LAMP IGNITED AND FUNCTIONED PROPERLY. THE COMPLAINT REPORT OF ¿UNIT IS BURNING CABLES/END-FITTINGS¿, WAS CONFIRMED. NOTE THAT WHEN THE MIRROR IS NOT IN PROPER POSITION HEAT FROM THE LAMP IS NOT DEFLECTED AND RADIATES OUT THROUGH THE PORT ON THE TURRET AND INTO THE ATTACHED CABLE. THE ROOT CAUSE OF THE DISLODGED MIRROR WAS NOT DETERMINED.

    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 THE UNIT IS BURNING CABLES/END-FITTINGS. ON (B)(6) 2016 CUSTOMER REPORTS ISSUE WAS FOUND DURING AN OPEN GALLBLADDER, ABOUT HALFWAY THROUGH THE PROCEDURE, NO HARM TO PATIENT. NO FURTHER INFORMATION AVAILABLE. #1 OF 2 RELATED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772526 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1