BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 12411594 · Received September 1, 2021

    Report

    Report Number
    2955842-2021-11050
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 5, 2021
    Report Date
    August 5, 2021
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H3. EVALUATION/CORRECTION INFORMATION CAN BE FOUND IN THE FOLLOWING FIELD: H10 - UCC REPLACED DWA. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE VIDEO PROCESSOR (VP) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED/REPLICATED REPORTED ISSUE. THE VP WAS INSTALLED WITH A PCA TEST SYSTEM WHICH LAUNCHED IN MAINTENANCE MODE TO PROGRAM UNIT SOFTWARE, THEN POWER CYCLED 10X WITH REPEAT OCCURRENCES OF ERROR 40084 AND ONE OCCURRENCE OF ERROR 23. AN ERROR 252 WAS ALSO THROWN AND THE UNIVERSAL (UNIT) CONTROLLER CARD (UCC) BOARD LEDS WERE NOT LIT, SO THE SYSTEM WAS REBOOTED AND AN ETHERNET CABLE WAS ROUTED FROM THE TEST COMPUTER TO THE UCC BOARD WHICH WAS ABLE TO BE RECOGNIZED AND PROGRAMMED AGAIN. THE SYSTEM THEN LAUNCHED IN NORMAL MODE WITHOUT ERROR AND ALL UCC BOARDS WERE LIT. THE SYSTEM POWER CYCLED 10 MORE TIMES WITHOUT ERROR. THE UCC BOARD WILL BE REPLACED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE VERIFIED THE REPORTED ISSUE OF VIDEO POWER FAILING TO POWER ON. LOGS REVEALED ERROR 23 POINTING TO BOTTOM PORT CONNECTED TO THE VIDEO PROCESSOR (VP). THE FSE REPLACED THE VP AND SYSTEM POWERED UP NORMALLY WITH NO RELATED ERRORS OR ISSUES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE VP UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED/ REPLICATED REPORTED ISSUE. THE VP WAS INSTALLED WITH A PCA TEST SYSTEM WHICH LAUNCHED IN MAINTENANCE MODE TO PROGRAM UNIT SOFTWARE, THEN POWER CYCLED 10X WITH REPEAT OCCURRENCES OF ERROR 40084 AND ONE OCCURRENCE OF ERROR 23. AN ERROR 252 WAS ALSO THROWN AND THE DWA BOARD LEDS WERE NOT LIT, SO THE SYSTEM WAS REBOOTED AND AN ETHERNET CABLE WAS ROUTED FROM THE TEST COMPUTER TO THE DWA BOARD WHICH WAS ABLE TO BE RECOGNIZED AND PROGRAMMED AGAIN. THE SYSTEM THEN LAUNCHED IN NORMAL MODE WITHOUT ERROR AND ALL DWA BOARDS WERE LIT. THE SYSTEM POWER CYCLED 10 MORE TIMES WITHOUT ERROR. THE DWA BOARD WILL BE REPLACED. A REVIEW OF THE SITE'S COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS RELATED TO THIS COMPLAINT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) LEAD TO THE PROCEDURE TO BE CONVERTED TO ANOTHER DV AND COULD LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT REPORTED, THIS FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONTACTED TECHNICAL SUPPORT AS THE VIDEO PROCESSOR FAILED TO POWER UP AND ALL POWER BUTTONS WERE BLINKING BLUE. THE CUSTOMER POWERED DOWN THE SYSTEM AND CYCLED EACH CONSOLE WHILE RESEATING THE BLUE FIBERS AS ADVISED, BUT UPON POWER UP SAME ISSUE OCCURRED. THE CUSTOMER VERIFIED CONNECTIONS ON THE ENDOSCOPE CONTROLLER (EC) AND THE VIDEO PROCESSOR (VP) AND STATED THE FIBER PORT ON THE CORE WAS RED. THE CUSTOMER PERFORMED ANOTHER HARD CYCLE ON THE VISION SIDE CART (VSC) AND RESEATED CONNECTIONS BUT ISSUE PERSISTED. THE CUSTOMER EXCHANGED OUT THE VSC AND CONTINUED WITH THE CASE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM WAS CHECKED PRIOR TO USE AND THERE WAS NO ISSUES. THE VIDEO PROCESSOR STOPPED WORKING AS SOON AS THE CUSTOMER PLUGGED THE CAMERA IN AFTER PORT PLACEMENT. THERE WAS NO REPORT OF PATIENT INJURY. ALL TROUBLESHOOTING STEPS WERE EXHAUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304942 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-27 N/A 00886874110898

    Patients

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