BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTREON¿

    MDR report key: 23706974 · Received December 3, 2025

    Report

    Report Number
    2024168-2025-11853
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 3, 2025
    Manufacturer
    LIGHTLAB IMAGING, INC.
    Product Code
    NQQ
    UDI-DI
    05415067036810
    PMA / PMN Number
    K150237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. IT WAS REPORTED THAT A CONTRAST BAG WAS PLACED ABOVE THE DOC HOLSTER, AND WAS NOT PROPERLY SEALED, WHICH RESULTED IN FLUID LEAKAGE ONTO THE UNIT. BURNING AND SMOKE FROM THE DOC HOLSTER WAS OBSERVED BY THE STAFF. THE SYSTEM WAS IMMEDIATELY DISCONNECTED WITH THE ASSISTANCE OF THE HOSPITAL¿S BIOMEDICAL ENGINEERING TEAM TO PREVENT FURTHER RISK. THERE WAS NO PATIENT INVOLVEMENT. FIELD SERVICE WAS COMPLETED, AND THE DOC HOLSTER WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. OPTIS¿ INTEGRATED NEXT OPERATION AND MAINTENANCE MANUAL STATES MECHANICAL ENCLOSURE: WARNING: DO NOT USE THE OPTIS INTEGRATED NEXT IF IT HAS BEEN DROPPED OR IN ANOTHER WAY EXPOSED TO MECHANICAL OR ELECTRICAL DAMAGE OR IF LIQUIDS HAVE PENETRATED THE HOUSING, OR THE USER OR PATIENT MAY BE EXPOSED TO ELECTRICAL SHOCK OR FAULTY READINGS MAY APPEAR. CONTACT YOUR SUPPLIER FOR FURTHER ACTION. THE OPTISI NEXT DOC HOLSTER RISK ASSESSMENT REPORT WAS REVIEWED AND AN EXAMPLE OF SMOKING/DEVICE EMITS ODOR CAN BE FOUND. FACTORS THAT MAY CONTRIBUTE TO SMOKING/DEVICE EMITS ODOR INCLUDE BUT ARE NOT LIMITED TO LIQUID INGRESS CAUSING THE SYSTEM TO SHORT. THE CAUSE OF THE REPORTED BURNING AND SMOKE FROM THE DOC HOLSTER WAS MOST LIKELY DUE TO THE USER ALLOWING AN IMPROPERLY SEALED CONTRAST BAG OVER THE DOC HOLSTER TO LEAK ONTO THE UNIT RESULTING IN LIQUID INGRESS AND DAMAGE TO THE ELECTRICAL COMPONENTS WITHIN THE DOC HOLSTER. PRODUCT WAS NOT RETURNED FOR EVALUATION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CONTRAST BAG WAS PLACED ABOVE THE DOC HOLSTER, AND WAS NOT PROPERLY SEALED, WHICH RESULTED IN FLUID LEAKAGE ONTO THE UNIT. BURNING AND SMOKE FROM THE DOC HOLSTER WAS OBSERVED BY THE STAFF. THE SYSTEM WAS IMMEDIATELY DISCONNECTED WITH THE ASSISTANCE OF THE HOSPITAL¿S BIOMEDICAL ENGINEERING TEAM TO PREVENT FURTHER RISK. THERE WAS NO PATIENT INVOLVEMENT. FIELD SERVICE WAS COMPLETED, AND THE DOC HOLSTER WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857688 ULTREON¿ SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) NQQ LIGHTLAB IMAGING, INC. 600132440 10194154 05415067036810

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown