BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G10-01 GENTUITY HF-OCT IMAGING SYSTEM

    MDR report key: 25283947 · Received May 26, 2026

    Report

    Report Number
    3011578544-2026-00024
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    June 10, 2024
    Report Date
    June 11, 2024
    Manufacturer
    GENTUITY, LLC
    Product Code
    NQQ
    PMA / PMN Number
    K230620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEMO CATHETER WAS DIFFICULT TO CONNECT, AND THE PIM PRODUCED NOISE BEFORE THE CATHETER BECAME STUCK. MULTIPLE CATHETERS COULD NOT BE CONNECTED, AND THE OPTICAL-SIDE CONNECTOR WAS FOUND MISALIGNED. INVESTIGATION SHOWED THE PIM PULLEY WAS LOOSE ON THE SPIN MOTOR, ALLOWING THE SPINDLE TO SLIP. THE COMPLAINT IS CONFIRMED.

    Description of Event or Problem · 0

    NMC COMPLAINT (B)(4) AFTER CASES, IN-SERVICES COMPLETED FOR STAFF. BRAND NEW DEMO CATHETER OPENED AND WAS DIFFICULT TO CONNECT. THE PIM STARTED MAKING A NOISE. AT COMPLETION OF DEMO, THE CATHETER GOT STUCK INSIDE OF THE PIM. WHEN CATHETER WAS REMOVED, THE CONNECTIONS WERE NOT ALIGNED. CONNECTION ERRORS IN YELLOW RECEIVED ON THE MONITOR. THE PIM CONNECTIONS ON THE LASER SIDE ARE NOT ALIGNING AND WILL NOT ACCEPT CATHETER CONNECTION. MULTIPLE CATHETERS ATTEMPTED. POWER DOWN AND POWER UP MULTIPLE TIME AND LASER INPUT IS 2 CASES COMPLETED AT DEBORAH, HEART, AND LUNG TODAY. STILL CROOKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73865 G10-01 GENTUITY HF-OCT IMAGING SYSTEM SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) NQQ GENTUITY, LLC G10-01 22J2008

    Patients

    Seq Age Sex Outcome Treatment
    1