BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 6138739 · Received December 1, 2016

    Report

    Report Number
    2523190-2016-00201
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 10, 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 HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 12/2/2016 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - A VISUAL INSPECTION FOUND NO VISIBLE, PHYSICAL DAMAGE. THE MLX WAS POWERED ON AND THE LAMP IGNITED. THE UNIT WAS LEFT "ON" FOR 20 MINUTES TO ALLOW THE LAMP TO WARM UP. THERE WAS NO ABNORMAL HEAT RADIATING THROUGH THE PORT IN THE TURRET DURING THIS TIME. NO MALFUNCTION, PERFORMED AS INTENDED. THE REPORTED COMPLAINT WAS NOT DUPLICATED; UNCONFIRMED. 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: THE MLX FUNCTIONED AS INTENDED. THE MLX LIGHT SOURCE WAS UPDATED WHERE NECESSARY AND WILL BE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS DEVICE GIVING OFF A LOT OF HEAT FROM THE PORT WHERE YOU PLUG IN THE HEADLIGHT. ON (B)(6) 16 CUSTOMER REPORTS THIS OCCURRED DURING BENCH TESTING NOT DURING A PROCEDURE, NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790115 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1