BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19726736 · Received July 11, 2024

    Report

    Report Number
    2955842-2024-16843
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 18, 2024
    Report Date
    June 18, 2024
    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
    IN
    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 CHECKED THE LED STATUS OF THE ENDOSCOPE CONTROLLER (EC), IT WAS IN OFF CONDITION. THE FSE RESET THE POWER CORD AND ALL OTHER CONNECTIONS OF THE EC, BUT THE ISSUE REMAINED. THE FSE REPLACED THE EC, AND THE PROBLEM WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE EC INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE CONTROLLER (EC) WAS INSTALLED INTO THE TEST SYSTEM AND FAILED WITH ERROR 319 AT STARTUP. FOR TROUBLESHOOTING, AT THE TEST BENCH, POWER WAS APPLIED TO THE EC AND FOUND THAT THE DUAL CAMERA INTERFACE BOARD (DCIB) BOARD HAS NO HEARTBEAT. PERFORMED LIGHT ENGINE SENSOR CHECK AND IS LESS THAN <5%.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM DISPLAYED NON-RECOVERABLE FAULT 319. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED LOGS AND CONFIRMED THE ERROR ON THE ENDOSCOPE CONTROLLER (EC). THE TSE SUGGESTED FOR A HARD POWER CYCLE AND RESET POWER CORD AT THE EC. HOWEVER, THE ISSUE DID NOT RESOLVE. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM DID INITIALLY POWER ON WITHOUT ERRORS. THE TSE WAS CONTACTED, AND FULL TROUBLESHOOTING WAS COMPLETED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426602 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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