BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22564846 · Received July 22, 2025

    Report

    Report Number
    2955842-2025-30997
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    July 1, 2025
    Report Date
    February 7, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF ANY MALFUNCTION OF AN INTUITIVE SURGICAL INC. (ISI) SYSTEM, INSTRUMENT OR ACCESSORY OCCURRING DURING THE PROCEDURE; THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: H2, H11. ADDITIONAL INFORMATION: INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) FOR FAILURE ANALYSIS EVALUATION. THERE WAS NO DATA FOUND IN THE ERROR LOG, TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. A VISUAL INSPECTION DID NOT REVEAL ANY ISSUES RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM, THE UNIT FUNCTIONED AS EXPECTED: IT ENERGIZED, CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL AND SEGMENTAL PANCREATECTOMY PROCEDURE, THE CASE WAS ULTIMATELY CONVERTED TO OPEN SURGERY DUE TO A VESSEL INJURY; NOT DUE TO THE TECHNICAL ISSUES. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) SCREEN HAD EXPERIENCED A LOST VIDEO SIGNAL AND CEASED FUNCTIONING; HOWEVER, THE IESU ISSUES OCCURRED PRIOR TO THE START OF THE PROCEDURE, AND THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THAT THE PROCEDURE COULD CONTINUE WITH THE SAME IESU. THE CONVERSION WAS PROMPTED BY AN UNSPECIFIED VESSEL INJURY THAT RESULTED IN BLEEDING, UNRELATED TO A TECHNICAL PROBLEM. ALTHOUGH THE ESTIMATED VOLUME OF BLOOD LOSS WAS NOT PROVIDED, HEMOSTASIS WAS SUCCESSFULLY ACHIEVED USING LIGATURES. THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767778 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-21 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.