BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18080850 · Received November 6, 2023

    Report

    Report Number
    2955842-2023-19974
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 20, 2023
    Report Date
    October 20, 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
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 30-OCT-2023, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP THE SYSTEM. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. NOT LONG AFTER POWERING UP, THE UNRECOVERABLE ERROR MESSAGE OCCURRED.

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE VERIFIED THE U-02 ERRORS ON THE ERBE GENERATOR AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND TRIGGERED A U-02 ERROR ON AN IN-HOUSE SYSTEM AT STARTUP. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A U-02 ERROR OCCURRED ON THE ERBE GENERATOR. THE SITE HAD REMOVED THE CABLES ON BACK OF THE ERBE GENERATOR AND RESTARTED THE ERBE GENERATOR WITH NO CHANGE. THE SITE ATTEMPTED TO USE A FORCE TRIAD GENERATOR TO COMPLETE THE CASE; HOWEVER, THEY WERE NOT ABLE TO USE IT. THE PROCEDURE WAS ABORTED. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174392 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-38 N/A 00886874110898

    Patients

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