BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22952948 · Received September 3, 2025

    Report

    Report Number
    2955842-2025-36078
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 14, 2025
    Report Date
    August 14, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: H2, H11. ADDITIONAL INFORMATION: THE MOVEMENTS OF THE SURGEON DID SCALE APPROPRIATELY TO THE INSTRUMENT; HOWEVER, THE INSTRUMENT DID NOT MOVE IN THE INTENDED DIRECTION. THE MOVEMENT WAS REVERSED ON THE X AND Y AXIS. THE ISSUE WAS PERSISTENT; THE CUSTOMER TRIED RESTARTING, RE-DOCKING, AND CHECKING CONNECTIONS.

    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 PERFORMED A UNIVERSAL SURGICAL MANIPULATOR TEST DRIVE AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED AND THE INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY PROCEDURE, THAT THE MOVEMENT OF THE MASTER TOOL MANIPULATOR (MTM) WAS INVERTED WHEN COMMANDED, NECESSITATING A CONVERSION. THE ISSUE OCCURRED IMMEDIATELY AFTER THE START OF THE PROCEDURE. IN AN EFFORT TO RESOLVE THE ISSUE, THE ENDOSCOPE CAMERA WAS RESEATED, AND THE SYSTEM WAS POWER CYCLED, BUT THE PROBLEM PERSISTED. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS THEN CONSULTED AND CONFIRMED THAT THE ENDOSCOPE CAMERA WAS POSITIONED CORRECTLY IN THE VERTICAL AXIS. THE TSE RECOMMENDED ADJUSTING THE ENDOSCOPE CAMERA AND ATTEMPTING MANUAL HAND CONTROL ASSIGNMENT FOR FURTHER TROUBLESHOOTING. DUE TO THE TIME REQUIRED FOR TROUBLESHOOTING, THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO A LAPAROSCOPIC APPROACH. ADDITIONAL PORTS WERE PLACED DURING THE CONVERSION, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE PATIENT TOLERATED THE CONVERSION AND DID NOT EXPERIENCE ANY POST-OPERATIVE COMPLICATIONS. THE SITE HAS REQUESTED A FIELD SERVICE ENGINEER (FSE) TO VISIT FOR FURTHER SYSTEM INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386531 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-13 N/A 00886874110744

    Patients

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