BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 7058639 · Received November 27, 2017

    Report

    Report Number
    2523190-2017-00147
    Event Type
    Injury
    Date Received
    November 27, 2017
    Report Date
    November 8, 2017
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    12/7/17 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS: COMPLAINT IS UNCONFIRMED; THIS IS DUE TO THE PRODUCT NOT BEING RETURNED FOR REVIEW. COMPLAINT WILL BE REOPENED IF PRODUCT IS RECEIVED. DEVICE HISTORY EVALUATION: DEVICE HISTORY RECORD REVIEWED, NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    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 MLX WAS SMOKING NEAR THE FIBEROPTIC PORT DURING SURGERY. ON (B)(6) 2017 CUSTOMER REPORTS . "ANTERIOR CERVICAL FUSION BEING PERFORMED, CAN'T SAY EXACTLY WHAT THE INJURY WAS. PER THE NURSE IN THE ROOM THERE WAS THE SMELL OF BURNING FLESH AS WELL AS SMOKE. THE NURSE STATED IT DID NOT APPEAR TO CAUSE ANY PERMANENT DAMAGE AT THE TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840264 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other