BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19140674 · Received April 18, 2024

    Report

    Report Number
    2955842-2024-13545
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 27, 2024
    Report Date
    March 27, 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
    AS
    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. FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE RETURN OF THE PRODUCT WAS ISSUED. AT THE TIME OF THIS REPORT, THE PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR(USM) WAS ANALYZED AND REPORTED FAILURE WAS CONFIRMED AND REPLICATED. REMOTE LOGS RECORDED ERROR 319 POINTING TO THE ACC. A VISUAL INSPECTION WAS PERFORMED AND MISALIGNMENT / DAMAGE TO THE ROLLING LOOP FIBER WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY (WITHOUT LYMPHADENECTOMY) SURGICAL PROCEDURE, THERE WAS A RECURRING ERROR 319 ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY ATTEMPTED TO RECTIFY THE ISSUE BY RESTARTING THE SYSTEM. TSE EXAMINED THE ERROR LOGS AND IDENTIFIED ERRORS 307 AND 319 REPORTED BY UNIVERSAL (UNIT) CONTROLLER CARD (UCC), ALONG WITH ERRORS 40084 REPORTED BY AXES CONTROLLER SPAR (ACS) IN USM 3, ALL INDICATING THAT THE AXES CONTROLLER CARRIAGE (ACC) BOARD INSIDE THE USM 3 WAS NOT RESPONDING. FOLLOWING THE TSE'S INSTRUCTIONS, THE CUSTOMER PERFORMED TWO HARD POWER CYCLES ON THE SYSTEM AND "EXERCISED" THE USM BETWEEN CYCLES, YET THE ISSUE PERSISTED. THE TSE NOTIFIED THE CUSTOMER THAT REPLACING THE USM 3 WAS NECESSARY. SUBSEQUENTLY, THE CUSTOMER INFORMED THE TSE THAT THE SURGEON OPTED TO PROCEED WITH THE PROCEDURE USING ONLY THREE ARMS. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND IT INITIALLY POWERED ON WITHOUT ERRORS.

    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
    1685485 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DA VINCI INSTRUMENTS AND ACCESSORIES