BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16081374 · Received January 1, 2023

    Report

    Report Number
    2955842-2022-16235
    Event Type
    Malfunction
    Date Received
    January 1, 2023
    Date of Event
    December 2, 2022
    Report Date
    December 2, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SYSTEM WOULD ERROR OUT WITH A RED FAULT AND THEN THE SYSTEM WOULD POWER OFF COMPLETELY, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISSUES NOTED WERE CAUSED BY THE AUXILIARY VIDEO BOARD (AVP) IN THE VISION SIDE CART (VSC) CORE. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE REPLACED THE OPERATING ROOM INTEGRATION INPUT/OUTPUT (ORI-IO) AND AUXILIARY VIDEO PROCESSOR (AVP) DUE TO ERROR 40063. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. DURING IN-HOUSE FAILURE ANALYSIS, THE ORI-IO WAS INSTALLED INTO THE PRINTED CIRCUIT ASSEMBLY (PCA) TEST SYSTEM AND WAS POWERED ON SHOWING NO ERRORS. THE ORI-IO WAS VISUALLY CHECKED WITH THE EXTERNAL LED TEST. THE ORI-IO RAN 10 POWER CYCLES AND LET THE SYSTEM SIT IDLE FOR 20 MINUTES WITH NO ISSUES. THIS UNIT COULD NOT REPRODUCE THE ISSUE. THE COMPLAINT REGARDING THE SYSTEM WOULD ERROR OUT WITH A RED FAULT WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS OF THE ORI-IO. THE AVP WAS ANALYZED AND THE REPORTED FAILURES WERE CONFIRMED AND REPLICATED. THE PCA WAS ABLE TO REPLICATE THE REPORTED PROBLEM BY INSTALLING THIS BOARD INTO THE SYSTEM AND TESTING ONSITE CONNECT. THE AVP BOARD FAILED TO COMMUNICATE WITH THE SYSTEM WITH NO BOOT. THERE WAS AN ERROR 310 AND 40068. THE COMPLAINT REGARDING THE SYSTEM WOULD ERROR OUT WITH A RED FAULT AND THEN THE SYSTEM WOULD POWER OFF COMPLETELY WAS CONFIRMED BASED ON THE FIELD EVALUATION AND FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER MIGHT HAVE HAD A SYSTEM DOWN AFTER THE START OF THE PROCEDURE DUE TO THE SYSTEM ERRORING OUT WITH A RED FAULT AND THEN THE SYSTEM WOULD POWER OFF COMPLETELY. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A PROCEDURE CHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT FAULTS ON THE SYSTEM. THE CUSTOMER STATED THAT WHILE THEY WERE TURNING THE SYSTEM OFF TO PERFORM A POWER CYCLE, THE SYSTEM WOULD ERROR OUT WITH A RED FAULT AND THEN THE SYSTEM WOULD POWER OFF COMPLETELY. AT THE TIME OF THE CALL, ACCESS TO THE LIVE LOGS WAS NOT AVAILABLE. THE TSE ASKED IF THERE WERE ANY CODE OR NUMBERS DISPLAYED WHEN THE RED FAULT PRESENTED ITSELF, BUT THE CUSTOMER STATED THERE WAS NO NUMBER. THE CUSTOMER STATED THAT THE FIELD SERVICE ENGINEER (FSE) WAS COMING IN LATER FOR ANOTHER ISSUE. THE TSE THEN CALLED THE CUSTOMER TO REQUEST THE POPUP LOGS TO BE TRANSLATED TO HELP THE FSE IN TROUBLESHOOTING OF THE SYSTEM. THE CUSTOMER PROVIDED THE EVENT LOGS TO THE TSE. THE TSE DECODED THE LOGS AND MOST OF THE ISSUES WERE ROOTED IN A 40068-ERROR POINTING TO THE ISI CORE CONTROLLER (ICC) BOARD. THERE WERE SOME ERRORS POINTING TO THE SURGEON SIDE CONSOLE (SSC) 2 AND UNIVERSAL MOTION CONTROLLER (UMC) BOARD BUT IT WAS POSSIBLE THE ROOT CAUSE WAS FROM THE ICC LOSING COMMUNICATION WITH OTHER COMPONENTS. THE FSE WAS TO INVESTIGATE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UPS ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391112 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-21 N/A

    Patients

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