BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25213746 · Received May 19, 2026

    Report

    Report Number
    3015488559-2026-00037
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 19, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. 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.

    Description of Event or Problem · 0

    IT WAS ALLEGED THAT THE SURGEON CONSOLE WENT INTO MEDIUM PRIORITY ALARM DURING SETUP FOR A VERSIUS TRAINER SESSION, DUE TO A TIMEOUT ON ONE OF THE SOFTWARE COMPONENTS. THIS ISSUE OCCURRED DURING NON-CLINICAL USE AND THERE WAS NO PATIENT INVOLVEMENT. SOFTWARE WAS RE-INSTALLED ON THE DEVICE AND THIS RESOLVED THE ISSUE. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9066 VERSIUS SURGICAL SYSTEM VERSIUS SURGEON CONSOLE SCV CMR SURGICAL LIMITED 05060548210045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown