BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25111188 · Received May 7, 2026

    Report

    Report Number
    3015488559-2026-00029
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 10, 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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 REPORTAND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED ADEATH OR SERIOUS INJURY. ALL INFORMATION KNOWN ATTHE TIME OF THIS REPORT HAS BEEN INCLUDED.

    Description of Event or Problem · 0

    THE SURGEON REPORTED THAT WHILST USING THE VERSIUS SURGEON CONSOLE, HE FELT THE POSITION OF THE ELECTROSURGERY BUTTON WAS UNCOMFORTABLE TO USE AND HE DEVELOPED HAND PAIN. THE SURGEON HAS BEEN ASKED FOR MORE INFORMATION REGARDING THE SEVERITY OF THE PAIN, NO INFORMATION HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599365 VERSIUS SURGICAL SYSTEM VERSIUS SURGEON CONSOLE SCV CMR SURGICAL LIMITED 05060548210045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male