BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEXAVUE

    MDR report key: 24203859 · Received January 28, 2026

    Report

    Report Number
    3008776287-2026-00024
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 28, 2026
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995220594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT AND FOUND THAT THE MEDICAL NETWORK ADAPTER (MNA) DECODER REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE MNA DECODER, TESTED THE FUNCTION AND OPERATION OF THE DEVICE AND CONFIRMED IT TO BE OPERATING TO SPECIFICATIONS. THE MNA DECODER SUBJECT OF THE REPORTED EVENT IS BEING RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THEIR HEXAVUE INTEGRATION SYSTEM EXPERIENCED "NO BUTTON CONTROL AND NO VIDEO ON THE MONITOR." THIS EVENT DID NOT OCCUR DURING A PATIENT PROCEDURE. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260012 HEXAVUE INTEGRATION SYSTEM KQM BLACK DIAMOND VIDEO, INC. HEXAVUE IP 00724995220594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown