BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22911744 · Received August 28, 2025

    Report

    Report Number
    2955842-2025-35528
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 6, 2025
    Report Date
    August 6, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 EVENT. THE FSE REPLACED THE PATIENT SIDE CART POWER CORD, TESTED THE SYSTEM, AND VERIFIED IT AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PROCEDURE, A STAFF MEMBER EXPERIENCED A TINGLING SENSATION AFTER TOUCHING THE POWER CORD OF PATIENT SIDE CART (PSC). A VISUAL INSPECTION OF THE POWER CORD REVEALED NO FRAYED, BROKEN, OR PROTRUDING WIRES, AND THERE WERE NO SIGNS OF THERMAL DAMAGE. THE STAFF MEMBER DID NOT REQUIRE ANY MEDICAL INTERVENTION FROM THE ELECTRICAL SHOCK. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT TECHNICIAN (TSE) WAS NOTIFIED AND ADVISED THAT AN ISI FIELD SERVICE ENGINEER (FSE) WOULD VISIT THE HOSPITAL TO REPLACE THE PSC POWER CORD AND CONDUCT AN ELECTRICAL SAFETY TEST FOLLOWING THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520443 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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