BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25081842 · Received May 5, 2026

    Report

    Report Number
    3015488559-2026-00024
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 5, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210021
    PMA / PMN Number
    K252111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    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. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS.

    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 THE SURGEON INFORMED HIM THAT DURING SURGERY THE INSTRUMENT BEDSIDE UNIT APPEARED TO WOBBLE INTERMITTENTLY. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE CONTINUED WITH NO COMPLICATIONS. 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 THE SURGEON INFORMED HIM THAT DURING SURGERY THE INSTRUMENT BEDSIDE UNIT APPEARED TO WOBBLE INTERMITTENTLY. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE CONTINUED WITH NO COMPLICATIONS. CMR SURGICALLTD DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITS PRODUCT IS DEFECTIVE OR THATITHAS CAUSED A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608358 VERSIUS SURGICAL SYSTEM VERSIUS INSTRUMENT BEDSIDE UNIT SCV CMR SURGICAL LIMITED 05060548210021

    Patients

    Seq Age Sex Outcome Treatment
    1