BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 22693533 · Received August 2, 2025

    Report

    Report Number
    2955842-2025-32634
    Event Type
    Malfunction
    Date Received
    August 2, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 7, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE POWER CORD FROM THE PATIENT SIDE CART (PSC) IN ORDER TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PART INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A FAULTY POWER CORD CONNECTED ON PSC LEADING TO AN INTERRUPTION IN AC POWER SUPPLY TO THE PSC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, POST-ANESTHESIA THERE WAS A DA VINCI SYSTEM MESSAGE FOR RUNNING ON BATTERY DURING THE START UP. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM THE TECHNICAL SERVICE ENGINEER (TSE). THE CUSTOMER WAS INSTRUCTED BY TSE FOR THE PATIENT SIDE CART (PSC) TO BE POWERED DOWN TO VERIFY THE CORRECT CONFIGURATION OF THE BREAKER AND THE EMERGENCY POWER OFF (EPO) BUTTON. THE TSE ALSO INSTRUCTED TO ENSURE THE AC CABLE WAS CONNECTED TO A FUNCTIONAL AC OUTLET. DESPITE REBOOTING, THE ISSUE PERSISTED. SUBSEQUENTLY, THE AC PLUG WAS TRANSFERRED TO AN ANESTHESIA SOCKET, CONFIRMED TO BE OPERATIONAL. THE TSE REQUESTED THE CUSTOMER TO VERIFY THAT THE POWER PLUGS WERE APPROPRIATELY CONNECTED TO THE PSC. REBOOTING YIELDED NO RESOLUTION. CONSEQUENTLY, THE CUSTOMER ELECTED TO TRANSFER THE PATIENT TO A DIFFERENT THEATER EQUIPPED WITH A XI SYSTEM. FURTHER TROUBLESHOOTING WAS CONDUCTED, INCLUDING A HARD POWER CYCLE OF THE ENTIRE SYSTEM AND RESEATING ALL BLUE FIBER CABLES, BUT THE ISSUE REMAINED UNRESOLVED. THE TSE PROPOSED CHECKING THE AC SUPPLY WITH ASSISTANCE FROM A BIOMEDICAL ENGINEER. DURING A FOLLOW-UP CALL, IT WAS CONFIRMED THAT THE BIOMEDICAL ENGINEER ASSESSED THE AC SOCKETS; HOWEVER, THE PSC CONTINUED TO LACK AC POWER. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049964 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-33 N/A 00886874115404

    Patients

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