BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23325438 · Received October 17, 2025

    Report

    Report Number
    2955842-2025-41838
    Event Type
    Injury
    Date Received
    October 17, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 8, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 ISI FSE WENT ON SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. A SYSTEM LOG REVIEW CONFIRMED THE REPORTED ERROR INDICATING THAT THE VOLTAGE WAS TOO LOW.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU GENERATOR WAS ANALYZED AND THE CUSTOMER REPORTED ERROR WAS FOUND DURING POWER-ON TESTING WHICH CONFIRMED THE FAULT OCCURRED IN THE FIELD. A VISUAL INSPECTION REVEALED NO RELATED ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN ERROR OCCURRED ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE CUSTOMER POWER CYCLED THE IESU AND THE SYSTEM, BUT THAT DID NOT CLEAR THE ERROR. THE ERROR CAME UP EVERY TIME THE CUSTOMER ACTIVATED MONOPOLAR AND BIPOLAR ENERGY. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED TO CHANGE THE MODE TO CLASSIC, BUT THIS DID NOT RESOLVE THE ERROR EITHER. ANOTHER SYSTEM WAS NOT AVAILABLE FOR USE. THE CUSTOMER STATED THAT THEY HAD A COVIDIEN VALLEY LAB GENERATOR, BUT NOT THE BLUE CABLE THAT CONNECTS FROM THE VISION SIDE CART TO THE VALLEY LAB. INTUITIVE RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW UP: THE PROCEDURE WAS CONVERTED TO OPEN. THERE WAS A PROCEDURAL DELAY OF AT LEAST 30 MINUTES.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267501 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.