BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23578686 · Received November 18, 2025

    Report

    Report Number
    2955842-2025-45517
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 25, 2025
    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
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU/ERBE) WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED PROBLEM WAS NOT CONFIRMED USING THE SYSTEM ERROR LOGS. UPON VISUAL INSPECTION THERE WAS A POSSIBLE ISSUE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE ERBE WAS TESTED USING THE SYSTEM, THE UNIT DISPLAYED ERRORS C-02 AND U-02 WHEN TESTING BIPOLAR AND IT WENT BACK ON THE INTUITIVE SPLASH SCREEN SHOWING MULTIPLE U-02 ERROR. THEN POWER CYCLED THE ERBE TO CHECK ERBE LOG AND U-02 ERROR SHOWED ON START. THE PROBABLE ROOT CAUSE COULD BE ATTRIBUTED TO FAULTY ELECTRICAL COMPONENTS INSIDE THE ERBE GENERATOR THROWING ERROR U-02. THIS ERROR INDICATED A CHECK MASTER COMMUNICATION FAILURE.

    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 WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE UNIT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE ERBE SCREEN WAS BLACK AND THE TEAM WAS ABLE TO COMPLETE THE PROCEDURE USING A THIRD-PARTY GENERATOR. THE ISSUE WAS REPORTED TO THE TECHNICAL SUPPORT AFTER COMPLETING THE PROCEDURE. THE OPERATING ROOM (OR) STAFF MEMBER EXPLAINED THAT THEY ATTEMPTED TO POWER CYCLE THE ERBE AND RESEAT THE POWER CORD, BUT THESE STEPS DID NOT RESOLVE THE ISSUE. AS A RESULT, THEY DECIDED TO MOVE ALL UPCOMING CASES TO OTHER DA VINCI SYSTEMS. NO LOGS WERE AVAILABLE AT THE TIME OF THE CALL. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362553 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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