BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI SP

    MDR report key: 20103080 · Received August 29, 2024

    Report

    Report Number
    2955842-2024-18658
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 2, 2024
    Report Date
    August 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. 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. ISI DID RECEIVE THE IESU INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE U-02 ERROR WAS CONFIRMED AND REPRODUCED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SITE REPORTED ERRORS ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR. THE SITE WAS GETTING THE U-02 ERROR. THEY POWER CYCLED THE GENERATOR, BUT THE ISSUE PERSISTED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) WAS CONTACTED AND THE CALLER WAS ADVISED TO REMOVE AND RECONNECT THE CABLE AND POWER CYCLE THE GENERATOR. THE ERROR CLEARED. AT AN UNSPECIFIED TIME, THE CUSTOMER CALLED BACK AND REPORTED U-02 ERROR RETURNED AND THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM. PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522678 DA VINCI SP VISION SYSTEM CART NAY INTUITIVE SURGICAL, INC 380941-33 N/A

    Patients

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