BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23058667 · Received September 15, 2025

    Report

    Report Number
    2955842-2025-37929
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 27, 2025
    Report Date
    November 24, 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
    WI, 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 REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE DUE TO BIPOLAR ENERGY NOT WORKING. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS RECEIVED THE ERBE FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    UPDATED ANNEX C - INV FINDINGS DESC 1 TO C0201 - ELECTRICAL/ELECTRONIC COMPONENT PROBLEM IDENTIFIED. UPDATED ANNEX D - CONCLUSION DESC 1 TO D02 - CAUSE TRACED TO COMPONENT FAILURE. UPDATED ANNEX D - CONCLUSION DESC 2 TO D15 - CAUSE NOT ESTABLISHED.

    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) OR ERBE WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPLICATE OR CONFIRM THE CUSTOMER-REPORTED COMPLAINT. THE REPORTED ISSUE COULD NOT BE CONFIRMED THROUGH SYSTEM LOG REVIEW. A VISUAL INSPECTION CONFIRMED THE UNIT WAS IN GOOD CONDITION. THE ERBE WAS TESTED ON THE SYSTEM AND SUCCESSFULLY CAUTERIZED ALL PORTS AND INSTRUMENTS WITHOUT ANY ISSUES. THE ERBE WAS THEN SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. THE REPORTED EVENT WAS NOT CONFIRMED AS FAILURE ANALYSIS FOUND NO FUNCTIONAL ISSUE. THE ERBE UNIT WAS VISUALLY INSPECTED AND EVALUATED FOR ITS MECHANICAL AND/OR ELECTRICAL CHARACTERISTICS. THE FAILURE ANALYSIS INVESTIGATIONS AND IN-HOUSE TESTING OF THE RETURNED PRODUCT REVEALED NO ISSUES RELATED TO THE CUSTOMER REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BIPOLAR ENERGY WAS NOT WORKING. CUSTOMER TRIED REPLACING THE INSTRUMENT, POWER CYCLING THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE, SWAPPING PORTS, AND CHANGING ARMS BUT ISSUES PERSISTED. TECHNICAL SUPPORT ENGINEER (TSE) INFORMED CUSTOMER THAT THE ISSUE COULD BE RELATED TO THE INSTRUMENT CORD. CUSTOMER WAS GOING TO TRY ANOTHER SET OF CORDS AND POSSIBLY BRING IN A THIRD-PARTY ESU. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983203 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A 00886874110898

    Patients

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