BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25055930 · Received May 1, 2026

    Report

    Report Number
    3015488559-2026-00021
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 1, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210045
    PMA / PMN Number
    K252111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 REGULATIONS. IF ANY FURTHER INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 DURING SURGICAL SET UP FOR A CHOLECYSTECTOMY PROCEDURE, THERE WAS AN UNRECOVERABLE ALARM (MPA). THERE WAS NO HARM TO THE PATIENT, BUT THE SURGEON DECIDED TO CONVERT FROM A ROBOTIC SURGERY TO A LAPAROSCOPIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212964 VERSIUS SURGICAL SYSTEM VERSIUS SURGEON CONSOLE SCV CMR SURGICAL LIMITED 05060548210045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown