BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19819904 · Received July 24, 2024

    Report

    Report Number
    2955842-2024-17082
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 27, 2024
    Report Date
    June 27, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 ELECTRO SURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND THE REPORTED FAILURE (ACTIVATION HAS BEEN INTERRUPTED DUE TO AN ERROR C-33) WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE FRONT BEZEL HAD A DEEP SCRATCH ON THE RIGHT SIDE. THE COVER HAD SCRATCHES ON THE LEFT SIDE. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED AN ERROR ON THE INTEGRATED ELECTRO SURGICAL UNIT. THE CUSTOMER ATTEMPTED TO TROUBLESHOOT THE ISSUE WITH MULTIPLE POWER CYCLES BUT THE ERROR CONTINUED TO OCCUR. THE CUSTOMER HAD A THIRD-PARTY GENERATOR AND CONNECTED IT TO THE SYSTEM TO CONTINUE THE CASE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356097 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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