BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23448025 · Received November 3, 2025

    Report

    Report Number
    2955842-2025-43707
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 2, 2025
    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
    GA, US
    Reporter Occupation
    NURSE
    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 COMPLAINT. THE FSE SAW TWO VISION SIDE CART (VSC) TOWERS IN THE ROOM AND DID NOT KNOW WHICH VSC HAD THE ISSUE. THE FSE SWAPPED THE ERBE GENERATOR ON SYSTEM SK1917, HOWEVER THE ORIGINAL ISSUE WAS ON SYSTEM SK4877 WHERE THE SETTING WAS ON SINGLE PAD INSTEAD OF DUAL. THE CUSTOMER CORRECTED THE SETTINGS AND WILL FOLLOW UP IF THE ISSUE REOCCURS. THE FSE SPOKE TO THE ROBOTICS COORDINATOR (ROCO) ON PATIENT IDENTIFIER (B)(6). THE ROCO INFORMED FSE THAT THE GROUNDING PAD WAS ON SINGLE PAD SETTING. FSE WALKED ROCO THROUGH SETTING THE ERBE GENERATOR BACK TO DUAL PAD CONFIGURATION. THE FSE TEXTED ROCO TO ASK HIM IF ISSUE WAS RESOLVED, BUT THE ROCO ADVISED THERE WERE NO MORE CASES UNTIL TOMORROW. FSE TEXTED IF IT WAS POSSIBLE TO USE TEST INSTRUMENTS TO CHECK THE GENERATOR BUT DID NOT GET A RESPONSE. THE FSE WENT ONSITE LATER THAT EVENING AND PLACED TEST INSTRUMENTS ON ROBOT AND MADE ENERGY WITHOUT ISSUE. SYSTEM WAS WORKING PROPERLY, AND NO PARTS WERE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A DA VINCI ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE USING THE CUSTOMER INFORMED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THE ERBE GENERATOR WAS DIFFICULT TO CONNECT AND THE GROUND PAD FAILING TO BE RECOGNIZED. INITIAL TROUBLESHOOTING INCLUDED CONFIRMATION OF USING A VALIDATED GROUND PAD AND VERIFICATION THAT THE ERBE GROUND PAD INDICATOR WAS SET TO SINGLE. THE TSE REVIEWED THE SYSTEM ERROR LOGS, BUT NO ERRORS WERE FOUND. THE ISSUE WAS UNABLE TO BE RESOLVED DURING TROUBLESHOOTING. SURGEON ELECTED TO DISABLE VSC SK4877 AND REPLACED IT WITH ANOTHER VSC. PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758429 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

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