BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 24840762 · Received April 10, 2026

    Report

    Report Number
    3015488559-2026-00011
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 10, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548211165
    PMA / PMN Number
    301548859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. A FIELD SERVICE ENGINEER WILL BE INSPECTING AND TESTING THEDEVICE, ONCE THE INVESTIGATION IS COMPLETE A SUPLEMENTAL REPORT WILL BE SUBMITTED TO FDA WITH THE RESULTS.

    Description of Event or Problem · 0

    ON (B)(6) 2026, DURING A RADICAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, THE SURGEON REPORTED AN ISSUE WITH BIPOLAR ENERGY. IT WAS REPORTED THAT "ONCE THE SURGEON STOPPED PRESSING THE ENERGY BUTTON IN THE JOYCON THE ENERGY KEPT ON FOR ABOUT THREE SECONDS, THE ENERGY ICON DISSAPPEARED FROM THE SCREEN BUT THE SOUND AND ENERGY FLOW KEPT ON". THE REPORTER CONFIRMED THERE WAS NO PATIENT HARM, NO IMPACT ON THE PATIENT AND THE PROCEDURE WAS COMPLETED AS PLANNED. AT THE TIME OF THIS REPORT NO FURTHER INFORMATION HAS BEEN RECEIVED. ONCE A FIELD SERVICE ENGINEER HAS COMPLETED HIS INVESTIGATION REPORT A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS. CMR SURGICAL LIMITED DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITSPRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537402 VERSIUS SURGICAL SYSTEM SURGEON CONSOLE SCV CMR SURGICAL LIMITED 05060548211165

    Patients

    Seq Age Sex Outcome Treatment
    1