BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21811466 · Received April 10, 2025

    Report

    Report Number
    2955842-2025-14054
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 18, 2025
    Report Date
    January 30, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PRODUCT HAS BEEN RECEIVED AND THE FA IS STILL IN PROGRESS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY CHECKED UPON POWERING ON THE SYSTEM AND WAS POWERED ON WITHOUT ERRORS. THERE WAS NO PATIENT INJURY. THE PROCEDURE SUCCESSFULLY COMPLETED ROBOTICALLY WITH THE FORCE TRIAD. THE PATIENT INFORMATION WAS NOT PROVIDED. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS.

    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 SYSTEM LOGS SHOWED 25913 M-36 ERRORS ON 03/18/2025. A VISUAL INSPECTION IDENTIFIED THAT THE UNIT HAS NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL IS IN DECENT CONDITION. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM AND FUNCTIONED AS EXPECTED. THE COMPLAINT WAS NOT CONFIRMED OR REPRODUCED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. THE UNIT WILL BE RETURNED TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR ADDITIONAL FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DID NOT RECOGNIZE MONOPOLAR OR BIPOLAR INSTRUMENTS WITH A "CHECK ENERGY CORD CONNECTION" MESSAGE. THE CUSTOMER REPORTED THAT REBOOTING THE IESU, REPLACING THE INSTRUMENTS AND ENERGY CABLES, AND SWITCHING THE ENERGY PORT FROM THE LOWER TO THE UPPER PORT DID NOT RESOLVE THIS ISSUE. THE CUSTOMER THEN DECIDED TO USE A FORCETRIAD FOR THIS PROCEDURE. THE TSE EXPLAINED TO THE CUSTOMER HOW TO INTEGRATE THE FORCETRIAD AND CONFIRMED THAT IT WORKED WITH THE SAME INSTRUMENTS AND ACCESSORIES. THE PROCEDURE WAS COMPLETING AS PLANNED 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
    478807 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-30 N/A

    Patients

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