BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18379227 · Received December 21, 2023

    Report

    Report Number
    2955842-2023-21515
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 1, 2023
    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
    MO, 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 FOUND THE SYSTEM TO BE FUNCTIONING UPON ARRIVAL. SYSTEM LOGS SHOWED ERROR 858 INTERMITTENTLY OVER THE LAST SEVERAL DAYS. THE FSE REPLACED THE SYSTEM POWER MANAGER (SPM) DUE TO THE MULTIPLE ERRORS DISPLAYED. ISI DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SPM WAS ANALYZED ON THE TEST SYSTEM. THE SYSTEM STARTED AT NORMAL MODE WITH NO ERRORS AND FAILURE MESSAGE. IT WAS VERIFIED ALL AXES WITH NO ERRORS AND FAILURE. THE SYSTEM PASSED AFTER TEN POWER CYCLES. THE UNIT REMAINED ON THE SYSTEM OVER THE WEEKEND WITH NO FAILURE AND NO ERROR MESSAGE. THE PATIENT SIDE CART (PSC) WAS DRIVEN IN AC MODE AND BATTERY MODE WITH NO ERROR MESSAGE AND NO FAILURE. AFTER CHECKING THE SPM STATUS ON BOTH AC MODE AND BATTERY MODE, THE CURRENT AND VOLTAGE IS IN NORMAL RANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, CUSTOMER REPORTED RECEIVING A PREVENTIVE MAINTENANCE ADVISORY (PMA) 858 MESSAGE. THE SYSTEM WAS IN A PROCEDURE AND THE SURGEON WAS OPERATING. THE TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED WITH CUSTOMER THAT THE SYSTEM WAS ON AC POWER AT THE TIME OF THE CALL. THE CUSTOMER WILL ATTEMPT TO CLEAR THE MESSAGE AFTER THE PROCEDURE WAS OVER AND WAS ASKED TO CALL BACK. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE REPORTER INDICATED THE ISSUE WAS IDENTIFIED DURING PROCEDURE AND PORTS WERE CONFIRMED TO BE PLACED. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM WITH NO ERRORS PRESENTED. THE PATIENT SIDE CART (PSC) DISPLAYED A PMA SYSTEM MESSAGE AND WAS UNABLE TO RUN THE SYSTEM ON BATTERY. TECHNICAL SUPPORT WAS CALLED TO TROUBLESHOOT AND RECOMMENDED THE STAFF TO PERFORM A POWER CYCLE WITH NO RESOLUTION. THE PSC WAS UNABLE TO BE CHARGED, AND IT WAS ADVISED TO CONTINUE TO HAVE THE PSC PLUGGED IN AN OUTLET TO CONTINUE THE PROCEDURE. THE REPORTER INDICATED THEY WERE ABLE TO COMPLETE THE PROCEDURE ROBOTICALLY. THERE WERE NO ABORTIONS/CONVERSIONS AT THIS TIME. NO HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288256 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

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