BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25315224 · Received May 28, 2026

    Report

    Report Number
    3015488559-2026-00052
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 28, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    PMA / PMN Number
    K252111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATION 803. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF FURTHER INFORMATION BECOMES AVAILABLE. CMR SURGICAL LIMITED DOES NOT CONSIDER THIS REPORT AND CONTENT TO BE AN ADMISSION THAT ITSPRODUCT IS DEFECTIVE OR THAT IT HAS CAUSED A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGICAL SET UP IT WAS IDENTIFIED THAT THE SHAFT OF A MONOPOLAR CURVED SCISSORS APPEARED TO HAVE A TEAR. THE INSTRUMENT WAS INSPECTED UNDER A MICROSCOPE AND IT WAS CONFIRMED THAT THE SHAFT INSULATION DAMAGE WAS PRESENT ON THE INSTRUMENT AS REPORTED. THIS WAS IDENTIFIED PRIOR TO CLINICAL USE, THE SURGICAL TEAM USED A NEW INSTRUMENT, NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248162 VERSIUS SURGICAL SYSTEM MONOPOLAR CURVED SCISSORS SCV CMR SURGICAL LIMITED 013309

    Patients

    Seq Age Sex Outcome Treatment
    1