BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSIUS SURGICAL SYSTEM

    MDR report key: 25146345 · Received May 12, 2026

    Report

    Report Number
    3015488559-2026-00032
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 11, 2026
    Manufacturer
    CMR SURGICAL LIMITED
    Product Code
    SCV
    UDI-DI
    05060548211158
    PMA / PMN Number
    K252111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CMR SURGICAL LIMITED IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REGULATIONS. WHEN THE DEVICE HAS BEEN RECEIVED AND INSPECTED BY CMR SURGICAL A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS. 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 AT THE BEGINNING OF A PROCEDURE ON (B)(6) 2026, THE SURGEON REPORTED DAMAGE TO THE BIPOLAR FENESTRATED GRASPER (BFG). THE INSTRUMENT WAS IDENTIFIED AS FAULTY IMMEDIATELY UPON INSERTION THROUGH THE TROCAR INTO THE ABDOMINAL CAVITY. THE SURGEON PROMPTLY POINTED OUT THE VISIBLE DAMAGE AND REQUESTED A REPLACEMENT. NO HARM TO PATIENT, PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 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 INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58237 VERSIUS SURGICAL SYSTEM BIPOLAR FENESTRATED GRASPER SCV CMR SURGICAL LIMITED 05060548211158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown