BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25298721 · Received May 27, 2026

    Report

    Report Number
    3015488559-2026-00049
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 5, 2023
    Report Date
    May 27, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    PMA / PMN Number
    K252111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    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 ASUPPLEMENTAL REPORT WILL BE SUBMITTED. CMR SURGICAL LTD, 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.

    Description of Event or Problem · 0

    RETROSPECTIVE DATA WAS ADDED TO THE REGISTRY WHICH ALLEGED THAT A NEPHECTOMY PROCEDURE REQUIRED TO BE CONVERTED TO LAPAROSCOPIC SURGERY. FOLLOW UP INFORMATION WITH THE SURGICAL TEAM, REPORTED THAT THE PATIENT HAD A COMPLEX ANATOMY. THE PATIENT EXPERIENCED NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428994 VERSIUS SURGICAL SYSTEM VERSIUS SURGEON CONSOLE SCV CMR SURGICAL LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1