BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23388306 · Received October 27, 2025

    Report

    Report Number
    2955842-2025-43016
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    October 1, 2025
    Report Date
    January 15, 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
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE OF ERROR M-02 IS ATTRIBUTED TO A FAULTY COMPONENT OF THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). M-02 ERRORS INDICATE A MODULE TIMEOUT ISSUE AND, THEREFORE, THE ACTIVATION WAS INTERRUPTED.

    Additional Manufacturer Narrative · 0

    THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS NOT ABLE TO CONFIRM ISSUE PER SYSTEM LOGS. UPON VISUAL INSPECTION, THE UNIT WAS IN GOOD COSMETIC CONDITION. THE IESU WAS TESTED USING A GOLDEN SYSTEM, AND ERRORS M-02-3 SHOWS UP ON STARTUP. IESU ERROR LOG SHOWS C-00 (B)(6) 2025 09:46 AM AND M-02 (B)(6) 2025 09:46 AM. AS A RESULT OF THESE FINDINGS, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AS OF THE DATE OF THIS REPORT, THE IESU HAS NOT YET BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE CAUTERY WAS NOT WORKING, AND THE CUSTOMER WAS GETTING AN ERROR M-02 FROM THE GENERATOR. SITE TRIED REBOOTING, TURNING OFF AND UNPLUGGING POWER BUT ISSUE PERSISTS. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED SWAPPING WITH ANOTHER VISION SIDE CART (VSC). THE SITE SAID THEY WERE GOING TO TRY THAT STEP. IT IS UNKNOWN IF THEY CONVERTED THE PROCEDURE TO ANOTHER DA VINCI SYSTEM. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2734798 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-30 N/A 00886874110898

    Patients

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