BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19945957 · Received August 8, 2024

    Report

    Report Number
    2955842-2024-17691
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 12, 2024
    Report Date
    July 12, 2024
    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 REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE IESU WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED FAILURE (ERROR M-02-3 ON START-UP AND MONOPOLAR NOT SEEN ON SYSTEM) WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM A WAS RUN IN NORMAL MODE. ADDITIONALLY, THE UNIT HAD SCRATCHES ON THE SIDES OF THE COVER. THE FRONT BEZEL WAS NOT CRACKED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATODUODENECTOMY SURGICAL PROCEDURE, NEITHER OF THE MONOPOLAR PORTS ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WOULD WORK. PRIOR TO CALLING, THE CUSTOMER SWAPPED THE VISION SIDE CART (VSC) AND WAS PROCEEDING WITH THE CASE. THE CUSTOMER STATED THEY WERE NOT CURRENTLY USING MONOPOLAR ENERGY SINCE THE SYSTEM SWAP, SO IT HAD NOT BEEN CONFIRMED THAT THE SAME INSTRUMENT WAS WORKING WITH THE NEW VSC. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SURGICAL SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION: THE ISI CLINICAL SALES ASSOCIATE (CSA) WAS NOT PRESENT DURING THE SURGICAL PROCEDURE BUT WAS INFORMED THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH THE NEW VSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770976 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES