BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22246692 · Received June 17, 2025

    Report

    Report Number
    2955842-2025-25602
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    June 2, 2025
    Report Date
    October 30, 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
    FL, 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 ERROR C-34. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE ERBE.

    Additional Manufacturer Narrative · 0

    UPDATED ANNEX C - INV FINDINGS DESC 1 TO C070601 - DEFORMATION/DISTORTION PROBLEM. UPDATED ANNEX C - INV FINDINGS DESC 2 TO C22 - APPROPRIATE INVESTIGATION FINDINGS TERM/CODE NOT AVAILABLE. UPDATED ANNEX D - CONCLUSION DESC 1 TO D11 - CAUSE TRACED TO USER. 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 THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED. A REVIEW OF THE LOGS CONFIRMED THAT THE ISSUE OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE ERBE WAS TESTED USING A WELL-KNOWN SYSTEM AND THE UNIT POWERED ON AND DISPLAYED ERROR C-34. THE UNIT WILL BE SENT BACK TO ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER INVESTIGATION. THE PROBABLE ROOT CAUSE COULD BE ATTRIBUTED TO FAULTY ELECTRICAL COMPONENTS INSIDE THE ERBE GENERATOR THROWING ERROR C-34. THIS ERROR INDICATES A LOWER VOLTAGE THAN EXPECTED DURING ENERGY ACTIVATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT MONOPOLAR WOULD NOT DELIVER ENERGY AND PRIOR TO CALLING USER HAD POWER CYCLED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE AND REPLACED GREEN MONOPOLAR ENERGY CABLE WITH NO CHANGE. ERROR C-34 WAS OBSERVED ON ERBE IN LOGS. TSE ADVISED ERBE WILL NEED TO BE REPLACED AND FOR CURRENT CASE OFFERED TO SWAP VISION SIDE CART (VSC) OR USE A FORCE TRIAD. TSE REVIEWED STATUS AND OPTIONS, AND CUSTOMER STATED NEITHER OPTION WAS AVAILABLE AND UNSURE HOW SURGEON WOULD PROCEED. CLINICAL SALES REPRESENTATIVE (CSR) CALLED FOR INFORMATION ON HOW TO CONNECT A FORCE TRIAD GENERATOR. TSE PROVIDED THE GUIDANCE. THE PROCEDURE OUTCOME WAS UNKNOWN, AND NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    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
    2547290 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N/A 00886874110898

    Patients

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