BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25092698 · Received May 6, 2026

    Report

    Report Number
    3015488559-2026-00026
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 6, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210021
    PMA / PMN Number
    K252111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. THE DEVICE WAS INSPECTED BY THE DISTRIBUTOR FIELD SERVICE ENGINEER. 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

    DURING NON-CLINICAL USE ON (B)(6) 2026 THERE WAS A NON-RECOVERABLE ALARM ON THE BEDSIDE UNIT. NO HARM TO A PATIENT OR USER, BUT IF THE ISSUE OCCURRED DURING SURGERY IT COULD LEAD TO A CONVERSION. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419052 VERSIUS SURGICAL SYSTEM VERSIUS INSTRUMENT BEDSIDE UNIT SCV CMR SURGICAL LIMITED 05060548210021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown