BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25110286 · Received May 7, 2026

    Report

    Report Number
    3015488559-2026-00028
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    March 19, 2026
    Report Date
    May 7, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210045
    PMA / PMN Number
    K252111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. A SUPPLEMENTAL REPORT WILL BE COMPLETED IF FURTHER INFORMATION BECOMES AVAILABLE. 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

    THE REPORTER ALLEGED THAT ON (B)(6) 2026, AT THE END OF SURGERY DURING SURGERY TEAR DOWN THERE WAS AN UNRECOVERABLE ALARM, THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO HARM TO PATIENT. DESPITE FOLLOW UP EMAILS TO THE REPORTER WE ARE STILL AWAITING FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213266 VERSIUS SURGICAL SYSTEM VERSIUS SURGEON CONSOLE SCV CMR SURGICAL LIMITED 05060548210045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown