BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO? RAS

    MDR report key: 24349722 · Received February 16, 2026

    Report

    Report Number
    1219930-2026-00964
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    November 27, 2025
    Report Date
    February 16, 2026
    Manufacturer
    SURGICAL
    Product Code
    SCV
    PMA / PMN Number
    K250725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM LITERATURE, A STUDY AIMED TO ANALYZE THE OUTCOMES, SAFETY, AND LEARNING CURVE OF TWO SURGEONS PERFORMING ROBOTIC-ASSISTED PARTIAL NEPHRECTOMY SURGERIES WITH THE HUGO RAS PLATFORM. FROM MAY 2023 TO OCTOBER 2024, 42 PATIENTS UNDERWENT PARTIAL NEPHRECTOMIES FOR RENAL TUMORS. ONE INTRAOPERATIVE COMPLICATION OCCURRED, AN IATROGENIC SPLENIC INJURY THAT WAS MANAGED WITH HEMOSTATIC AGENTS WITHOUT FURTHER OPERATIVE COMPLICATIONS. "ROBOTIC-ASSISTED PARTIAL NEPHRECTOMY WITH THE HUGO-RAS SYSTEM: INITIAL EXPERIENCE, SURGICAL OUTCOMES, AND LEARNING-CURVE ASSESSMENT." CENTRAL EUROPEAN JOURNAL OF UROLOGY, PUBLISHED: NOV. 27, 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408243 HUGO? RAS MODULAR ELECTROMECHANICAL SURGICAL SYSTEM SCV SURGICAL MRASC0001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R