BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22651928 · Received July 29, 2025

    Report

    Report Number
    2955842-2025-31968
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 10, 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
    FR
    Reporter Occupation
    003

    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. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE DUE TO INTERMITTENT BIPOLAR TOOL DETECTION. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON FIELD EVALUATION. A RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED FOR THE RETURN OF THE ERBE.

    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 RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ERROR WAS CONFIRMED BUT NOT REPLICATED. IN ERROR LOG, THE M-36 AND C-00 ERRORS WERE FOUND, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM WHERE IT FUNCTIONED AS EXPECTED. THE UNIT ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF ERROR M-36 IS ATTRIBUTED TO INSTALLATION ISSUES PREVENTING ENERGY ACTIVATION. THE INSTRUMENT MAY BE INSTALLED ON THE PATIENT SIDE CART ARM, BUT THE ENERGY CORD MAY NOT BE PROPERLY CONNECTED TO THE INSTRUMENT AND/OR GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE BIPOLAR WAS NOT WORKING, AND ATTEMPTS WERE MADE USING SEVERAL CAUTERY CORDS ON BOTH PORTS. THE INSTRUMENT WAS INTERMITTENTLY DETECTED, AND THE CUSTOMER USED THE VESSEL SEALER WITH THE E-100 INSTEAD OF THE BIPOLAR INSTRUMENTS. THERE WAS A NEED FOR FURTHER RESOLUTION BY A FIELD ENGINEER. TROUBLESHOOTING STEPS WERE COMPLETED, AND ADDITIONAL TROUBLESHOOTING WAS REQUIRED, POTENTIALLY INVOLVING CHECKING WITH A BRAND-NEW CAUTERY CORD OR REPLACING THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE GENERATOR. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO PATIENT HARM.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088034 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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