BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22552686 · Received July 21, 2025

    Report

    Report Number
    2955842-2025-30860
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 25, 2025
    Report Date
    February 12, 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
    IT
    Reporter Occupation
    003

    Narratives

    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 ISSUE AND REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). 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.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H8 FIELD - UPDATED TO INITIAL USE OF DEVICE, INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS BUT WAS NOT ABLE TO REPRODUCE THE ISSUE DURING IN-HOUSE TESTING. 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 THE UNIT FUNCTIONED AS EXPECTED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. WHILE A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED, THE PROBABLE ROOT CAUSE OF ERROR M-02 IS ATTRIBUTED TO A FAULTY COMPONENT IN THE IESU. M-02 ERRORS INDICATE A MODULE TIMEOUT ISSUE AND, THEREFORE, THE ACTIVATION WAS INTERRUPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY RADICAL WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, ERROR M-02 HAD OCCURRED ON THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). PRIOR TO THE CUSTOMER CONTACTING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE), THE CUSTOMER HAD REBOOTED AND RESET THE MONOPOLAR BIPOLAR CABLES, BUT THE REPORTED EVENT REOCCURRED. THE CUSTOMER USED AN EXTERNAL GENERATOR FOR THE MONOPOLAR EFFECT. THE SYSTEM LOG REVIEW REVEALED ERROR M-02. THERE WAS NO PATIENT INJURY OR HARM. THE PROCEDURE WAS COMPLETING AS PLANNED 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
    2785638 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-45 N/A 00886874110898

    Patients

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