BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18340019 · Received December 15, 2023

    Report

    Report Number
    2955842-2023-21366
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 24, 2023
    Report Date
    November 24, 2023
    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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 EVENT. THE FSE CONFIRMED THE U-02 ACTIVATION ERROR AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE IESU INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED, PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE REPORTED U-02 ERROR WAS CONFIRMED AND REPRODUCED. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED UMBILICAL HERNIA TAPP SURGICAL PROCEDURE, THE CUSTOMER WAS EXPERIENCING A U-02 ERROR ON THE INTEGRATED ELECTRO SURGICAL UNIT. PRIOR TO CALLING, THE SITE TRIED TO REBOOT THE SYSTEM SEVERAL TIMES WITH NO CHANGE. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) INFORMED THE SITE THAT THEY COULD TRY TO CONNECT A FORCE TRIAD GENERATOR OR BRING IN ANOTHER VISION SIDE CART (VSC) IF ONE WAS AVAILABLE. THE CUSTOMER THEN ENDED THE CALL. NO OTHER INFORMATION WAS PROVIDED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE TECHNICIAN DETERMINED IT WAS A BAD GENERATOR, AND IT HAS BEEN REPLACED. THEY TRIED TO USE ENERGY DURING THE CASE, AND IT HAD ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267740 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31 N/A 00886874110898

    Patients

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