BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18966153 · Received March 23, 2024

    Report

    Report Number
    2955842-2024-12730
    Event Type
    Malfunction
    Date Received
    March 23, 2024
    Date of Event
    March 5, 2024
    Report Date
    March 5, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 THE REPORTED ERROR WAS CONFIRMED AND REPRODUCED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WITHOUT ANY ERROR. DURING INSPECTION, IT WAS OBSERVED THAT THE PRESENCE PINS WERE STICKY/STUCK CAUSING AN INSTRUMENT ENGAGEMENT ISSUE. ERROR 31009 WAS CONFIRMED POINTING TO AN INSTRUMENT ENGAGEMENT ISSUE.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED FOR USE. ISI HAS NOT RECEIVED THE USM FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LOGS SHOWED A UNIVERSAL SURGICAL MANIPULATOR (USM) 4 CANNULA SENSOR ERROR AFTER THE START OF THE PROCEDURE. THE SITE SAID THEY UNDOCKED USM 4 AND DOCKED USM 1 AND CONTINUED IN THE CASE. THE OPERATING ROOM STAFF CALLED BACK IN AFTER THE PROCEDURE TO TROUBLESHOOT THE ISSUE FURTHER. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RAN THE CUSTOMER THROUGH A HARD POWER CYCLE AND EMERGENCY POWER OFF, BUT ISSUE PERSISTED AND USM 4 LEDS WERE STILL YELLOW. THE TSE NOTICED 31009 ERROR IN LOGS FOR USM 4 AND HAD THE CUSTOMER INSPECT CARRIAGE POGO PINS. CENTER POGO PIN ON CARRIAGE WAS FOUND TO BE STUCK IN THE DOWN POSITION. THE TSE WALKED THE CUSTOMER THROUGH EXERCISING THE PIN AND IT POPPED BACK UP AND USM LED STATUS TURNED BLUE. THE TSE HAD THE CUSTOMER EXERCISE THE PIN SEVERAL TIMES TO ENSURE IT POPPED BACK UP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED DURING THE PROCEDURE WHEN PORTS WERE ALREADY PLACED. THE SITE TRIED TO CHANGED INSTRUMENTS SEVERAL TIMES, BUT THE YELLOW BLINKING LIGHT CONTINUED. THE SURGEON THEN DISABLED AND DISCONTINUED USE OF THAT UNIVERSAL SURGICAL MANIPULATOR (USM). THE SITE WAS ORIGINALLY USING 3 USMS BUT DISCONTINUED USE OF USM4 AND COMPLETED THE PROCEDURE WITH USMS 1, 2, AND 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892995 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

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