BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17074068 · Received June 6, 2023

    Report

    Report Number
    2955842-2023-15969
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    January 19, 2022
    Report Date
    January 19, 2022
    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
    SZ
    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 REMOVED AND REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT IESU) AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE IESU ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS BUT THE REPORTED FAILURE OF ERRORS ON THE IESU COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM REFLECTED ERROR 25913 ALONG WITH C71 ON THE INTEGRATED ELECTRO SURGICAL UNIT (IESU). THE CUSTOMER ALREADY POWER CYCLED THE IESU BUT THE ISSUE REMAINED AFTER THIS ACTION. PRIOR TO CALLING FOR TECHNICAL SUPPORT, THE CUSTOMER ALREADY SWAPPED THE VISION SIDE CART (VSC) DUE TO THE IESU ISSUE. AN EXTERNAL IESU WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094523 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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