BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25251687 · Received May 22, 2026

    Report

    Report Number
    3015488559-2026-00044
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 22, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    PMA / PMN Number
    K252111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    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. THE BATTERY WILL BE REPLACED. 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
    611882 VERSIUS SURGICAL SYSTEM VERSIUS INSTRUMENT BEDSIDE UNIT SCV CMR SURGICAL LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1