BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22573434 · Received July 23, 2025

    Report

    Report Number
    2955842-2025-31199
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 26, 2025
    Report Date
    January 20, 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
    FR
    Reporter Occupation
    NURSE
    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.

    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 FOUND THE REPORTED C-34 ERROR WAS CONFIRMED AND REPRODUCED DURING POWER-ON TESTING, INDICATING THE FAULT OCCURRED IN THE FIELD. A VISUAL INSPECTION REVEALED NO RELATED ISSUES. THE UNIT WILL BE SENT TO THE ORIGINAL EQUIPMENT MANUFACTURER FOR FURTHER ANALYSIS. THE PROBABLE CAUSE OF ERROR C-34 IS ATTRIBUTED TO A FAULTY ELECTRICAL COMPONENT INSIDE THE ERBE GENERATOR. THIS ERROR INDICATES A LOWER VOLTAGE THAN EXPECTED DURING ENERGY ACTIVATION. THIS ERROR CAN BE RESOLVED THROUGH TROUBLESHOOTING OR REPLACEMENT OF THE GENERATOR.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECTED DEVICE EXHIBITED ENDOSCOPY IMAGES THAT COULD NOT BE DISPLAYED AND PRINTED CIRCUIT BOARD FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785330 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A 00886874110898

    Patients

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