BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23984086 · Received January 6, 2026

    Report

    Report Number
    2955842-2026-00427
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 12, 2025
    Report Date
    January 6, 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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE VISITED THE SITE AND REPLACED THE INTEGRATE ELECTRO SURGICAL UNIT (IESU) TO CORRECT THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU GENERATOR WAS ANALYZED AND FOUND REPORTED ISSUE COULD NOT BE DIRECTLY CONFIRMED ON SYSTEM LOGS, THOUGH SEVERAL ERBE AND ERROR LOGS (C-06, M-18, M-11, C-84, M-B1, M-0B) ALIGNED WITH THE EVENT. FUNCTIONAL TESTING ON-SITE WAS SUCCESSFUL. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE CANNOT BE DETERMINED BASED ON THE FAILURE ANALYSIS RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED REGARDING A C-84 INTERNAL ERROR ON THE ERBE WHILE USING THE VESSEL SEALER (VS) INSTRUMENT. ALTHOUGH THE VS INSTRUMENT FUNCTIONED, AN ERROR TONE WAS PRESENT DURING ENERGY ACTIVATION. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) INFORMED THE CUSTOMER THAT THE ERROR COULD BE CAUSED BY BITES THAT WERE TOO SMALL IN THE VS INSTRUMENT JAWS; HOWEVER, THE CUSTOMER CONFIRMED THE BITES WERE SUFFICIENT. THE TSE HAD THE CUSTOMER POWER CYCLE THE ERBE, BUT THE CUSTOMER CHOSE NOT TO USE THE VS INSTRUMENT FOR THE REMAINDER OF THE CASE. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47168 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-39 N/A 00886874110898

    Patients

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