BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21055505 · Received January 2, 2025

    Report

    Report Number
    2955842-2024-23619
    Event Type
    Injury
    Date Received
    January 2, 2025
    Date of Event
    December 4, 2024
    Report Date
    December 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED THE ENDOSCOPIC CONTROLLER (EC) DUE TO MULTIPLE ERRORS. THE SYSTEM WAS THEN TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE ENDOSCOPE CONTROLLER; HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS NOT BEEN COMPLETED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE REVEALED THERE WERE RELATED SYSTEM ERRORS THAT DID OCCUR DURING THE SURGICAL PROCEDURE.

    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 VISUALLY INSPECTED AND THERE WERE NO ISSUES FOUND RELATED TO THE REPORTED FAILURE. IN THE SYSTEM LOGS, AN ILLUMINATOR POWER CONTROL MONITORING ERROR MESSAGE AND EC HEALTH MONITORING - COLOR CONTROL WARNING ERROR MESSAGE WERE IDENTIFIED. THESE ERRORS CONFIRM THE FAULT OCCURRED AT THE CUSTOMER SITE DUE TO AN ISSUE WITH THE LIGHT ENGINE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THE FIREFLY ISSUE IS ATTRIBUTED TO AN ISSUE WITH THE LIGHT ENGINE OF THE ENDOSCOPE CONTROLLER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE FIREFLY FEATURE WAS NOT WORKING. THE CUSTOMER STATED THAT THE ICG DYE WAS VISIBLE WITH THE NAKED EYE, BUT WHEN THEY SWITCH TO FIREFLY THE SCREEN GOES GREY AS NORMAL, BUT THE FIREFLY WAS NOT ILLUMINATED. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) IDENTIFIED SEVERAL ENDOSCOPE CONTROLLER (EC) HEALTH MONITORING ERRORS. THE TSE RECOMMENDED A SYSTEM POWER CYCLE AND HARD POWER CYCLE OF THE VISION SIDE CART (VSC); HOWEVER, THE SURGEON WAS UNABLE TO POWER CYCLE OR PERFORM THE TROUBLESHOOTING STEPS AT THE TIME. IT WAS NOTED THAT DUE TO THE UNAVAILABILITY OF THE FIREFLY FEATURE, THERE WAS MORE BLOOD LOSS. THE FOLLOWING INFORMATION IS UNKNOWN: THE SOURCE AND CAUSE OF THE BLEEDING, THE BLOOD LOSS VOLUME ASSOCIATED THE BLEEDING, AND WHAT MEDICAL INTERVENTION (IF ANY) WAS RENDERED DUE TO THE COMPLICATION. ISI HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910189 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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