BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22173493 · Received June 10, 2025

    Report

    Report Number
    2955842-2025-24404
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 15, 2025
    Report Date
    May 15, 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
    BE
    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. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND FOUND THE REPORTED FAILURE (ERBE C-34 WHEN MONOPOLAR INSTRUMENT IS ACTIVATED) WAS CONFIRMED AND REPLICATED. DURING POWER-ON TEST, THE C-34 ERROR WAS FOUND, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. BASED ON FAILURE ANALYSIS, THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A LOWER VOLTAGE THAN EXPECTED DURING ENERGY ACTIVATION, WHICH MAY BE INDICATIVE OF A FAULTY ELECTRICAL COMPONENT WITHIN THE GENERATOR. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE WAS NOT SURE IF THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH SAME DA VINCI ERBE IESU GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RETZIUS SPARING PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO INFORM THAT THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATED ERROR C-34 WHEN ACTIVATING THE MONOPOLAR INSTRUMENTS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED ERROR C-34 AND ALSO FOUND ERROR M-18 POINTING TO INTERNAL HF AND COMMUNICATION ISSUE OF THE ERBE. PRIOR TO THE CALL, THE SITE POWER CYCLED THE ERBE, REPLACED THE INSTRUMENT CABLES AND USED OTHER PORT. THE SURGEON CONFIRMED THAT THE ISSUE DID NOT OCCUR WHEN ACTIVATING THE BIPOLAR INSTRUMENTS. THE TSE CONFIRMED THAT THERE WAS NO DEVICE (LIKE OTHER ESU) CAUSING POSSIBLE INTERFERENCE. THE OTHER SYSTEM WAS IN USE (THE TSE CONFIRMED VIA LOG). THE TSE VERIFIED IF THEY HAD THE FORCE TRIAD AND THE ENERGY ACTIVATION CABLE. THE SITE STATED THE FORCE TRIAD WAS AVAILABLE BUT THE NOT THE ENERGY ACTIVATION CABLE. THE TSE REQUESTED THE CALLER TO CHECK IN THE VIDEO SIDE CART (VSC) DRAWER, OPERATING ROOM (OR) AND THEIR OTHER SYSTEM BUT THE CALLER/OR STAFF DID NOT FIND IT NOR WAS AWARE OF THIS OPTION TO CONNECT THE FORCE TRIAD. THE TSE INFORMED THE CALLER HOW TO CONNECT AS THE CALLER STATED HE WOULD CONTINUE TO SEARCH FOR THE ENERGY ACTIVATION CABLE. DESPITE MISSING MONOPOLAR FUNCTION, THE SURGEON ELECTED TO CONTINUE USING THE BIPOLAR ONLY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265814 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-39 N/A 00886874110898

    Patients

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