BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21811452 · Received April 10, 2025

    Report

    Report Number
    2955842-2025-14070
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 14, 2025
    Report Date
    November 26, 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
    FL, US
    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 A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) WAS TESTED ON AN IN-HOUSE SYSTEM. THE GENERATOR SHOWED ERRORS 1-71 AND M-02-3 DURING STARTUP. ADDITIONAL M-02, C-00, M-1C, M-0B, M-B0 ERRORS WERE FOUND IN LOGS. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. WHILE A DEFINITIVE ROOT-CAUSE CANNOT BE ESTABLISHED DURING IN-HOUSE TESTING, A COMMON ROOT CAUSE FOR ERRORS C-00 AND M-02 CAN BE ATTRIBUTED TO A FAULTY COMPONENT OF THE IESU. C-00 AND 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 SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED ERRORS C-00 AND M-02 ON THE ERBE GENERATOR. THE CUSTOMER COULD NOT RESOLVE THE ISSUE AND CONVERTED THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC PROCEDURE TO CONTINUE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER STATED THAT THEY RESTARTED THE ERBE GENERATOR, AND THE CASE WAS COMPLETED. NO CLARIFICATION OF THE PROCEDURE CONVERSION WAS PROVIDED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492324 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-12 N/A

    Patients

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