BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23175390 · Received September 29, 2025

    Report

    Report Number
    2955842-2025-39861
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 12, 2025
    Report Date
    December 16, 2025
    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
    CI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    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 ERBE TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS ANALYZED AND FOUND THAT THE ERBE RETURNED FOR FAILURE ANALYSIS WITH REPORTED PROBLEM: "ERBE REPLACEMENT ERROR M-36". THE REPORTED PROBLEM WAS ABLE TO BE CONFIRMED USING ARTEMIS, ERROR M-36 09/25/2025 08:50:28 AM. UPON VISUAL INSPECTION THERE WAS NO ISSUE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE ERBE WAS TESTED USING SYSTEM, THE UNIT ENERGIZED AND CAUTERIZED AL PORTS AND INSTRUMENTS WITHOUT AN ISSUE. ERBR LOG SHOWS M-36 AND M-B0 ERROR. AS A RESULT OF THESE FINDINGS, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED BECAUSE THE UNIT IS AN OEM PRODUCT AND CANNOT BE OPENED ON SITE FOR FURTHER INVESTIGATION. THE ERBE WILL BE SENT TO OEM FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE IS COULD NOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS REPLACED BY THE FSE TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE THE IESU INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE G3 DATE WAS INCORRECT OF 12/24/2025 IN THE LAST SUBMITTED FOLLOW UP MDR. THE CORRECT G3 DATE IS 11/24/2025.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ERRORS KEEP APPEARING AFTER POWER CYCLE AND RESTARTS OF THE SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED 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
    1945582 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A

    Patients

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