BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 21017377 · Received December 26, 2024

    Report

    Report Number
    2955842-2024-23645
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 5, 2024
    Report Date
    December 5, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 POWERED THE SYSTEM ON WITH BOTH CONSOLES CONNECTED TO THE TOWER. THE SYSTEM POWERED ON, BUT NEITHER CONSOLE WOULD INITIALIZE. THE TOUCHPAD ON CONSOLE 2 SAID "NOT CONNECTED TO SYSTEM." THE BLUE LIGHT ABOVE THE FIBER CABLE ON CONSOLE 2 DID NOT ILLUMINATE. THE FSE POWERED THE SYSTEM DOWN AND UNPLUGGED CONSOLE 2 FROM THE TOWER. THE FSE POWERED THE SYSTEM ON AND CONSOLE 1 INITIALIZED WITH NO ISSUES. THE FSE POWERED THE SYSTEM DOWN, SWAPPED FIBER CABLES BETWEEN CARTS, AND ONLY PLUGGED CONSOLE 2 INTO THE TOWER. THE FSE POWERED THE SYSTEM ON, BUT CONSOLE 2 WOULD NOT INITIALIZE AND THE SAME "NOT CONNECTED TO SYSTEM" MESSAGE APPEARED ON THE CONSOLE TOUCHPAD. THE FSE REPLACED THE CARD CAGE (CCC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS; HOWEVER, THE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMMON COMPUTE CONTROLLER (CCC) WAS ANALYZED AND ERROR 32321 WAS CONFIRMED AND REPLICATED. REVIEWED SYSTEM ERROR LOGS AND CONFIRMED THAT ERROR 32321 DID TRIGGER IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. UNIT WAS INSTALLED ON THE KNOWN GOOD IN-HOUSE SYSTEM AND SYSTEM COULD NOT COMPLETE STARTED UP. THERE WAS A "CONSOLE IS NOT CONNECTED OR NOT POWERED ON" MESSAGE THAT APPEARED ON THE SYSTEM. THE POWER BUTTON ON THE CONSOLE WAS FLASHING BLUE. THESE SYMPTOMS ARE SIGN OF A BRICKED CCC UNIT. FAILURE ANALYSIS PERFORMED BENCH TEST ON THIS UNIT AND CONFIRMED THAT THE UNIT IS BRICKED. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY A QUALITY ENGINEER. INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: 32321 (RES: NODE DISCOVERY PARTIAL LINKUP TIMEOUT. (REASON: DISCOVERY_STATE_IDLE_LONG_ENOUGH). THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A FAULTY TEGRA MODULE WHICH CAUSE THE CCC TO BE BRICKED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM SHUT DOWN AFTER THEY TRIED TO CONNECT A SECOND CONSOLE TO THE SYSTEM. THE SITE RESTARTED AND GOT A 32321 ERROR. THE TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CLINICAL SALES REPRESENTATIVE (CSR) TO ONLY CONNECT OR DISCONNECT BLUE FIBER CABLES WITH SYSTEM OFF. THE SITE CONTINUED WITH THE CASE AND INFORMED THEY WOULD DO HARD RESTART OF SYSTEM AFTER THE CASE TO TRY AND GET THE CONSOLE TO CONNECT. THE CSR CALLED BACK TO INFORM THAT THEY WERE UNABLE TO GET THE SECOND CONSOLE TO COMPLETE POST WHEN CONNECTED DIRECTLY TO THE TOWER OR DAISY CHAINED TO THE FIRST CONSOLE. THE LIVE LOGS WERE NOT POPULATING. THE TSE WALKED THE CALLER THROUGH HARD POWER CYCLING THE TOWER, CONSOLES AND CONNECTING BOTH CONSOLES DIRECTLY TO THE TOWER. THEY POWERED ON FROM THE TOWER AND BOTH CONSOLES POWERED ON, BUT THE SECOND CONSOLE DID NOT MOVE ERGONOMICS OR MASTER TOOL MANIPULATOR (MTM) AND DID NOT COMPLETE POST. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING THE PROCEDURE AFTER PORT PLACEMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85640 DAVINCI 5 SURGEON SIDE CART NAY INTUITIVE SURGICAL, INC 380730-45

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.