BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25239465 · Received May 21, 2026

    Report

    Report Number
    3015488559-2026-00041
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 21, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. THE DEVICE WILL BE INSPECTED. 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

    IT WAS ALLEGED THAT AN INSTRUMENT BEDSIDE UNIT WENT INTO MEDIUM PRIORITY ALARM DURING SURGERY SETUP. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING THE VERSIUS SURGICAL SYSTEM, INCLUDING ANOTHER INSTRUMENT BEDSIDE UNIT. NO DELAY OR PATIENT HARM WAS REPORTED IN RELATION TO THIS EVENT. THE BEDSIDE UNIT WAS DIAGNOSED TO HAVE A LOW BACKUP BATTERY VOLTAGE. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396571 VERSIUS SURGICAL SYSTEM VERSIUS INSTRUMENT BEDSIDE UNIT SCV CMR SURGICAL LIMITED 05060548210021

    Patients

    Seq Age Sex Outcome Treatment
    1