BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25160472 · Received May 13, 2026

    Report

    Report Number
    3015488559-2026-00034
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 13, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210021
    PMA / PMN Number
    K252111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. THIS REPORT SHOWS ALL INFORMATION AVAILABLE AT THE TIME OF SUBMISSION.

    Description of Event or Problem · 0

    THE REPORTER ALLEGED THAT DURING PLANNED MAINTENANCE THE INSTRUMENT BEDSIDE UNIT (IBSU) HAD A UNRECOVERABLE ALARM. NO HARM TO ANY USER OR PATIENT. THE FIELD SERVICE ENGINEER REPLACED THE ARM BACK UP BATTERY PRIOR TO THE SURGERY, THE BSU WAS FUNCTIONAL AND THE SURGERY WENT AHEAD AS PLANNED. AT THE TIME OF THIS REPORT NO OTHER INFORMATION IS AVAILABLE. CMR SURGICAL 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
    339583 VERSIUS SURGICAL SYSTEM VERSIUS INSTRUMENT BEDSIDE UNIT SCV CMR SURGICAL LIMITED 05060548210021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown