BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20529209 · Received October 24, 2024

    Report

    Report Number
    2955842-2024-21075
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 1, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND FOUND THE ARMNET WAS DISABLED. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM (RMA 302596500040) INVOLVED IN THE COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT CONFIRMED AND REPLICATED ERROR WHERE IT FAILED USM AGC CURRENT PROMPTING ERROR 32056. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. THE FSE ALSO REPLACED ANOTHER USM WHILE PERFORMING THE FIELD EVALUATION DUE TO ERROR 23000 AND 23002. ISI RECEIVED THE USM (RMA 302596500080) TO PERFORM FA. SYSTEM LOGS CONFIRMED ERROR 23000. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT PASSED. THE USM WAS TESTED ON A PATIENT SIDE CART FIXTURE PLATFORM WHERE IT FAILED SENSORS CHECK ON THE YAW. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SYSTEM TRIGGERED A NON-RECOVERABLE FAULT. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND FOUND 32056 POINTING TO THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3. PRIOR TO CALLING IN, THE CUSTOMER POWER CYCLED THE SYSTEM, AND THE ERROR CAME BACK AT POWER UP. THE TSE HAD THE CUSTOMER HARD POWER CYCLE THE PATIENT SIDE CART (PSC) AND THE ERROR CAME BACK AT POWER UP. THE TSE HAD THE CUSTOMER DISABLE THE USM 3. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY USING 3 USMS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND IT INITIALLY POWERED ON WITHOUT ERRORS. THE FAULT OCCURRED MID PROCEDURE AND SITE DISABLED THE ARM. PATIENT DEMOGRAPHIC WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579101 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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