BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20457423 · Received October 15, 2024

    Report

    Report Number
    2955842-2024-20652
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 19, 2024
    Report Date
    September 19, 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
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THERE WERE NO ERRORS UPON MULTIPLE ACTIVATIONS.

    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. FSE REPLACED THE ERBE TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ORDER HAS BEEN CREATED TO DISPATCH AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) TO THE CUSTOMER'S SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER-REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE BOVIE PENCIL WAS NOT WORKING. THE CUSTOMER WAS GETTING ERRORS WHEN TRYING TO USE THE BOVIE PENCIL WITH THE INTEGRATED ELECTROSURGICAL UNIT (ERBE). THE CUSTOMER TRIED A NEW BOVIE PENCIL AND REBOOTING THE ERBE, BUT THE ISSUE REMAINED. THE BOVIE PENCIL WAS PLUGGED INTO THE LOWER MONOPOLAR PORT. THE CUSTOMER THEN USED THE BOVIE PENCIL WITH THE VALLEY LAB GENERATOR AND IT WORKED FINE. THE DA VINCI INSTRUMENTS HAD NO ISSUES WHEN USED WITH THE ERBE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VIEWED SYSTEM LOGS AND FOUND ERRORS C-82, 2-87, C-83, 1-87, AND M-02. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425907 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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