BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25090994 · Received May 6, 2026

    Report

    Report Number
    3015488559-2026-00019
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 6, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548210045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    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. 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 THE SURGEON CONSOLE WENT INTO A MEDIUM PRIORITY ALARM DUE TO LEFT HAND CONTROLLER ARM. THIS WAS RECOVERED, HOWEVER, WHEN THE SURGEON CONTINUED THE SURGERY THE MEDIUM PRIORITY ALARM REOCCURRED. THE PROCEDURE WAS CONVERTED TO MANUAL LAPAROSCOPIC APPROACH. NO HARM WAS REPORTED IN RELATION TO THIS EVENT. THE REPORTED (DISTRIBUTOR) PROVIDED CMR SURGICAL WITH A PHOTO OF A FRAYED CABLE ON THE LEFT HAND CONTROLLER ARM. THE MALFUNCTIONING PART WAS REPLACED BY THE DISTRIBUTOR. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295650 VERSIUS SURGICAL SYSTEM VERSIUS SURGEON CONSOLE SCV CMR SURGICAL LIMITED 05060548210045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown