BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23937475 · Received December 31, 2025

    Report

    Report Number
    2955842-2025-50317
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 8, 2025
    Report Date
    January 22, 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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 SURGICAL UNIT (IESU).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 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 CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FSE'S FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTOR SURGICAL UNIT (IESU) WAS ANALYZED AND FOUND VISUAL INSPECTION DID NOT REVEAL ANY ABNORMALITIES RELATED TO THE REPORTED EVENT. FUNCTIONAL TESTING WAS PERFORMED USING THE SYSTEM PLATFORM, AND THE UNIT POWERED ON AND SUCCESSFULLY CAUTERIZED ACROSS ALL PORTS AND INSTRUMENTS WITHOUT ISSUE. A REVIEW OF THE ERBE INTERNAL LOG ALSO REVEALED ERRORS C-84 AND M-18. THE COMPLAINT REGARDING ERBE ACTIVATION HALTED FOR BIPOLAR AND MONOPOLAR COULD NOT BE CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE CAN BE ATTRIBUTED TO THE FAULTY ERBE GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED REPEATED ENERGY ACTIVATION FAILURES ON THE INTEGRATED ELECTROSURGICAL UNIT ERBE GENERATOR FOR BOTH BIPOLAR AND MONOPOLAR INSTRUMENTS. THE TECHNICAL SERVICE ENGINEER (TSE) CONFIRMED THE REPORTED ISSUE AND RELATED ERRORS IN THE SYSTEM LOGS. THE CUSTOMER RESTARTED THE ERBE, REPLACED THE INSTRUMENTS AND ENERGY CABLES, AND CONNECTED THE INSTRUMENTS TO SEPARATE ARMS BUT THE ISSUE REMAINED. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT FURTHER, THE TSE INFORMED THE CUSTOMER THAT THE ERBE WOULD NEED TO BE REPLACED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY. THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING POSSIBLE ADDITIONAL PORT PLACEMENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564216 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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