BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 24922250 · Received April 20, 2026

    Report

    Report Number
    3015488559-2026-00014
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 20, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. ALTHOUGH THE DEVICE WAS USED SUCCESSFULLY FOLLOWING THE ALLEGED EVENT, INSPECTION OF THE DEVICE IS NECESSARY TO ENSURE THAT THE EVENT DOES NOT REOCCUR.

    Description of Event or Problem · 0

    REPORTER ALLEGED THAT, FOLLOWING START UP, THE SURGEON CONSOLE SCREEN DISPLAYED NO IMAGE. NO IMAGE WAS DISPLAYED ON THE AUXILIARY DISPLAY (EXTERNAL TO VERSIUS SURGICAL SYSTEM). THE REPORTER ALLEGED THAT THE ISSUE WAS RESOLVED VIA POWER CYCLING THE SURGEON CONSOLE THREE TIMES, AFTER WHICH THE DISPLAY WAS VISIBLE AS NORMALLY AND THE PROCEDURE COULD BE PERFORMED. NO HARM WAS REPORTED IN RELATION TO THIS EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. CMR SURGICAL LTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367364 VERSIUS SURGICAL SYSTEM VERSIUS SURGEON CONSOLE SCV CMR SURGICAL LIMITED 05060548210045

    Patients

    Seq Age Sex Outcome Treatment
    1