BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 8638561 · Received May 23, 2019

    Report

    Report Number
    2523190-2019-00071
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 13, 2019
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    FCW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 00MLX LIGHT SOURCE ALONG WITH A AX2100BIF HEADLIGHT CONTAINING A 001388-LX9 PREMIUM FIBER OPTIC CABLE AND A GRAY-COLORED, NON-INTEGRA FIBER OPTIC CABLE WAS RETURNED. THE NON-INTEGRA CABLE WAS NOT PREMIUM QUALITY AND UNSUITED FOR USE WITH THE HIGH ILLUMINATION MLX LIGHT SOURCE. INSPECTION OF THE GRAY, 7 FOOT NON-INTEGRA FIBER OPTIC CABLE FOUND THE METAL LIGHT SOURCE-END WAS BENT, BURNT AT THE TIP. THE GLASS CAP IN THE END OF THE METAL CONNECTOR WAS MELTED. CABLE IS NOT A PREMIUM FIBER OPTIC CABLE REQUIRED FOR USE WITH THE MLX LIGHT SOURCE. FUNCTIONAL TESTING OF THE MLX LIGHT SOURCE WITH THE RETURNED AX2100BIF HEADLIGHT (SERIAL NUMBER (B)(4)) DETERMINED THE SYSTEM OPERATED WITHIN SPECIFICATIONS. THE REPORTED COMPLAINT WAS UNCONFIRMED. NO SMOKING, MELTING OR FIRE OCCURRED DURING THE EVALUATION. THE ROOT CAUSE IS CONSIDERED USER ERROR; USE OF AN UNQUALIFIED FIBER OPTIC CABLE. DEVICE IDENTIFIER: 10381780167969.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    N/A.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, THE 00MLX MLX 300W XENON LIGHTSOURCE STARTED SMOKING WITHIN 30 SECONDS OF BEING TURNED ON. IT WAS UNCLEAR FROM THE REPORT WHETHER THE UNIT ALMOST CAUGHT ON FIRE OR CAUGHT ON FIRE, BUT THE UNIT SHUT OFF IMMEDIATELY. THE FIBEROPTIC LINES WERE MELTED. IT WAS UNKNOWN IF THERE WAS PATIENT CONTACT, AND A SURGICAL DELAY. THERE WAS NO PATIENT INJURY/DEATH ALLEGED. CLARIFICATION REQUEST HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429333 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1