BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22443257 · Received July 8, 2025

    Report

    Report Number
    2955842-2025-28963
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 17, 2025
    Report Date
    January 12, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE ERBE IESU TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS COMPLETED. THE INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: ERBE ENERGY ACTIVATION HALTED BY AN INSTRUMENT OR INSTRUMENT CABLE CONNECTED TO THE LOWER BIPOLAR PORT ON THE ERBE.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D9, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) FOR FAILURE ANALYSIS EVALUATION. AN ERROR CODE WAS IDENTIFIED IN THE ERROR LOG, CONFIRMING THAT A FAULT OCCURRED IN THE FIELD. A VISUAL INSPECTION REVEALED NO ISSUES RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM, WHERE THE IESU UNIT FUNCTIONED AS EXPECTED. THE UNIT ENERGIZED, CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT NEPHRECTOMY PROCEDURE, WHEN THE BIPOLAR ENERGY WAS ACTIVATED, THERE WAS NO ENERGY DELIVERY FROM THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE IESU WAS ABANDONED AFTER THE START OF THE PROCEDURE AND THE SURGEON WAS ABLE TO CONTINUE WITH THE PROCEDURE ROBOTICALLY WITH THE E-100 GENERATOR AND A VESSEL SEALER EXTEND INSTRUMENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839030 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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