BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVIDIMAGE 4K

    MDR report key: 23881558 · Received December 23, 2025

    Report

    Report Number
    3008776287-2025-00009
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 23, 2025
    Manufacturer
    BLACK DIAMOND VIDEO, INC.
    Product Code
    KQM
    UDI-DI
    00724995195113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 TO INSPECT THE UNIT AND FOUND THAT THE CABLE COVER WAS NOT FULLY SECURED TO THE DISPLAY, RESULTING IN THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE CABLE COVER. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE CABLE COVER TO THEIR VIVIDIMAGE 4K SURGICAL DISPLAY FELL OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532184 VIVIDIMAGE 4K SURGICAL DISPLAY KQM BLACK DIAMOND VIDEO, INC. RLM314K3 00724995195113

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown