BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19540751 · Received June 14, 2024

    Report

    Report Number
    2955842-2024-15590
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 20, 2024
    Report Date
    May 20, 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
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 REPRODUCED THE 319 FAULT ON NODE F. THE FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) TO SOLVE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS ANALYZED AND THE REPORTED FAILURE (ERROR 319) WAS CONFIRMED VIA THE ERROR LOGS AND REPLICATED IN-HOUSE. THE SITE'S LOGS SHOWED MULTIPLE 319 ERRORS POINTING TOWARD THE AXES CONTROLLER CARRIAGE (ACC). THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED A 319 ERROR POINTING TOWARD THE ACC. THE UNIT WAS ALSO TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE CHECK ALL BOARDS PRESENT AND THE FIBER TESTS POINTING TOWARDS THE ROLLING LOOP AND THE ACC. A GOLDEN ACCP PCA WAS INSTALLED IN THE CARRIAGE AND THE UNIT PASSED THE CHECK. ALL BOARDS PRESENT AND FIBER TEST ON RETRY. THE UNIT PASSED ALL OTHER REQUIRED TESTS THEREAFTER. DURING THE INVESTIGATION, THERE WAS NO DAMAGE OR FLUID INTRUSION NOTICED INSIDE THE CARRIAGE OR ON THE ACCP PCA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A NON-RECOVERABLE FAULT ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 1. PRIOR TO CALLING, THE CUSTOMER HAD POWER CYCLED THE SYSTEM TWO TIMES, BUT THE ISSUE PERSISTED. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SUPPORT ENGINEER (TSE). A SYSTEM LOG REVIEW CONFIRMED THE OCCURRENCE OF ERROR 319 ON THE USM 1. THE CUSTOMER FOLLOWED THE TSE'S TROUBLESHOOTING STEPS, BUT THE ERROR RETURNED UPON STARTUP. THE CUSTOMER DISABLED USM 1 AND RECOVERED THE FAULT SUCCESSFULLY. THE CUSTOMER CONTINUED WITH THE PROCEDURE WITH THE REMAINING 3 USMS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER CONFIRMED THAT THE SYSTEM WAS POWERED UP AT THE BEGINNING OF THE DAY AND THERE WERE NO ERRORS DETECTED. THE NON-RECOVERABLE FAULT OCCURRED WHEN THE USER WAS DOCKING THE SYSTEM. THE PORTS WERE PLACED BEFORE THE ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766893 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES