BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G10-01 GENTUITY HF-OCT IMAGING SYSTEM

    MDR report key: 25260165 · Received May 22, 2026

    Report

    Report Number
    3011578544-2026-00020
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Report Date
    March 25, 2024
    Manufacturer
    GENTUITY, LLC
    Product Code
    NQQ
    PMA / PMN Number
    K230620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SOFTWARE WAS INTENTIONALLY DESIGNED TO ENSURE ALL DISTAL FRAMES ARE CAPTURED, FOLLOWING FEEDBACK COLLECTED FROM THE FIELD AND OUR MEDICAL ADVISORS. THIS DESIGN CHANGE WAS MADE IN 2022 AND THE CHANGES WERE VALIDATED THROUGH REGRESSION ANALYSIS AND RE-TESTING. THIS OFTEN RESULTS IN REPEATED DISTAL FRAMES. FUTURE SOFTWARE DEVELOPMENTS WILL ADDRESS THIS ISSUE BY DETECTING THE REPEATED FRAMES.

    Description of Event or Problem · 0

    I HAVE RECENTLY BEEN REVIEWING PULLBACKS TO CREATE STUDY CASES FOR FUTURE EDUCATION. I NOTICED THE DISTAL 10MM OF THE PULLBACK HAVE BEEN REPETITIVE FRAMES. I DECIDED TO DO AN INVESTIGATION TO SEE HOW FAR BACK I COULD SEE THE DISTAL 10 MM OF THE PULLBACKS BEING REPETITIVE. I COMPILED A WORD DOCUMENT WITH PICTURE SNAPS. ACCORDING TO WHAT I HAVE ON MY LAPTOP IT APPEARS TO HAVE STARTED AROUND ON (B)(6) 2022. THE JUNE PULLBACKS I HAVE ALL APPEAR TO BE NORMAL AND IN JULY IT STARTED. I HAVE PULLBACKS FROM A VARIETY OF SITES. I AM NOT SURE IF WE UPDATED SOFTWARE IN JUNE/JULY OF 2022 TO QUARK PRIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382465 G10-01 GENTUITY HF-OCT IMAGING SYSTEM SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) NQQ GENTUITY, LLC G10-01

    Patients

    Seq Age Sex Outcome Treatment
    1