BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18043995 · Received October 31, 2023

    Report

    Report Number
    2955842-2023-19761
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 13, 2023
    Report Date
    October 13, 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
    TX, US
    Reporter Occupation
    003

    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 E-100 GENERATOR TO RESOLVE THE REPORTED 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 AND THE CUSTOMER REPORTED COMPLAINT WAS REPLICATED/CONFIRMED. THE E-100 WAS INSTALLED INTO THE TEST SYSTEM, AND IT FAILED. THE "POWER" AND "BIPOLAR" LED TURNED RED AND WOULD NOT CUT/SEAL.

    Additional Manufacturer Narrative · 0

    NTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE'S ISI CLINICAL SALES REPRESENTATIVE (CSR) AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE E-100 GENERATOR WAS NOT REPLACED IN ORDER TO COMPLETE THE PROCEDURE. SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM POWERED ON WITH NO ERRORS. THE PATIENT'S DEMOGRAPHIC INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE E-100 GENERATOR WAS NOT WORKING. THE CUSTOMER CYCLED THE E-100 POWER SWITCH, BUT THE E-100 CAME BACK UP DURING PROCEDURE AND THE POWER BUTTON WAS RED ALONG WITH THE LED ABOVE THE PORT. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED IF THE CUSTOMER COULD ATTEMPT TO POWER CYCLE THE E-100. THE CUSTOMER ATTEMPTED THIS, BUT THE NON-RECOVERABLE FAULT CAME BACK. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091549 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES