BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G10-01 GENTUITY HF-OCT IMAGING SYSTEM

    MDR report key: 25222157 · Received May 19, 2026

    Report

    Report Number
    3011578544-2026-00006
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    February 6, 2024
    Report Date
    February 6, 2024
    Manufacturer
    GENTUITY, LLC
    Product Code
    NQQ
    PMA / PMN Number
    K230620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS STATED DURING AN EVAL FEEDBACK DISCUSSION THAT THE PHYSICIAN DID NOT BELIEVE THE GENTUITY SOFTWARE MEASUREMENTS ARE CORRECT. OCT DATA WERE RECEIVED AND INVESTIGATED. THE SOFTWARE, THE CONSOLE, AND THE HARDWARE PERFORMED AS INTENDED. IMAGE CALIBRATION APPEARED CORRECT, INDICATING THAT MEASUREMENTS ARE ALSO CORRECT.

    Description of Event or Problem · 0

    NMC COMPLAINT (B)(4). DR. POTLURI STATED DURING AN EVAL FEEDBACK DISCUSSION THAT HE (OVERALL) DOES NOT BELIEVE THE GENTUITY SOFTWARE MEASUREMENTS ARE CORRECT. I HAVE PROVIDED THE LOGS AND FILES FOR THE LAST CASE THAT I COMPLETED WITH HIM WHEN HE MADE A SIMILAR COMMENT. THE ONLY AREA HE POINTED OUT TO ME THAT HE WAS QUESTIONING WAS THE LUMEN DIAMETER MEASURING 2.2MM. LOGS AND IMAGES WERE OBTAINED AND SUBMITTED TO NATALIE G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191422 G10-01 GENTUITY HF-OCT IMAGING SYSTEM SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) NQQ GENTUITY, LLC G10-01 23K0201

    Patients

    Seq Age Sex Outcome Treatment
    1