BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24526056 · Received March 5, 2026

    Report

    Report Number
    2955842-2026-15178
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 5, 2026
    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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. CORE POWER TRAY ASSEMBLY HAS BEEN REPLACED TO CORRECT THE REPORTED ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY ENCOUNTERED A REPEATED NON-RECOVERABLE ERROR 8 . THE USER ATTEMPTED MULTIPLE SYSTEM RESTARTS, BUT THE ISSUE PERSISTED. THE TSE CONDUCTED A VIDEO CALL TO GUIDE THE USER THROUGH SHUTTING DOWN THE SYSTEM, SWITCHING OFF THE CIRCUIT BREAKER TO THE VISION SIDE CART, ENSURING INTERNAL MAINS CABLES WERE SECURE, CYCLING THE CORE POWER SWITCH, AND RETURNING ALL SWITCHES TO THE ON POSITION. DESPITE THESE EFFORTS, THE ERROR CONDITION REMAINED UNCHANGED. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586592 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