BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MLX 300W XENON LIGHTSOURCE

    MDR report key: 8454139 · Received March 26, 2019

    Report

    Report Number
    2523190-2019-00045
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 6, 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 · 0

    THE PRODUCT WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE MLX LIGHT SOURCE FOUND CUSTOMER APPLIED LABELS, THE POWER ENTRY MODULE WAS LOOSE, AND THE REAR CHASSIS PANEL WAS DENTED. INTERNAL INSPECTION FOUND THE HEAT EXTENDED MIRROR WAS LOOSE IN THE UNIT AND CHIPPED. THE MIRROR HOLDER WAS NOT DAMAGED. THE ATTENUATOR SHIELD WAS BURNT ALONG WITH THE ORIFICE FOR THE WOLF PORT. FUNCTIONAL TESTING FOUND THE LAMP IGNITION WAS INTERMITTENT AND THE ATTENUATOR FUNCTIONED PROPERLY. THE REPORTED COMPLAINT WAS CONFIRMED FROM THE EVALUATION. THE IMPACT THAT CAUSED THE DENT IN THE REAR CHASSIS PANEL ALSO CAUSED THE HEAT EXTENDED MIRROR TO DETACH FROM ITS HOLDER. THIS CONDITION RESULTED IN THE FULL INTENSITY OF THE LIGHT BEAM TO PENETRATE THE TURRET BURNING THE ATTENUATOR SHIELD AND THE WOLF PORT. THE LIGHT SOURCE WAS PHYSICALLY DAMAGED. THE ROOT CAUSE IS CONSISTENT WITH ROUGH HANDLING; MISUSE - USER ERROR. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. DEVICE IDENTIFIER: (B)(4).

    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. LINKED TO MFG. REPORT NUMBER: 2523190-2019-00046.

    Description of Event or Problem · 1

    1 OF 2 REPORTS. IT WAS REPORTED THAT ON (B)(6) 2019, THE 00MLX MLX 300W XENON LIGHTSOURCE UNIT WAS OVERHEATING. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 FROM THE CUSTOMER STATED THAT THERE WAS NO SMOKE OR FLAME NOTED. THE PATIENT WAS PREPPED FOR SURGERY. THERE WAS AN APPROXIMATE 10-MINUTE PRODUCT PROBLEM DELAY HOWEVER, NO PATIENT IMPACT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245968 MLX 300W XENON LIGHTSOURCE N/A FCW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1