BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25257171 · Received May 22, 2026

    Report

    Report Number
    3015488559-2026-00046
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 22, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210045
    PMA / PMN Number
    K252111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 ADEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS ALLEGED THAT DURING A SACROCOLOPPEXY PROCEDURE ON (B)(6) 2026 THERE WAS A NON RECOVERABLE ALARM AND THE PROCEDURE WAS CONVERTED TO MANUAL LAPAROSCOPIC APPROACH. NO HARM WAS REPORTED IN RELATION TO THISEVENT. AND THE REPORTER CONFIRMED THERE WAS MINIMAL DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475766 VERSIUS SURGICAL SYSTEM VERSIUS SURGEON CONSOLE SCV CMR SURGICAL LIMITED 05060548210045

    Patients

    Seq Age Sex Outcome Treatment
    1