BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24692059 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18379
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    December 2, 2025
    Report Date
    March 25, 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
    GM
    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. FSE REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND FOUND TO HAVE A SYSTEM-LEVEL ELECTRONIC OR COMMUNICATION FAILURES. THE COMPLAINT WAS CONFIRMED BASED ON THE RESULTS OF THE INVESTIGATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. BASED ON THE EVIDENCE, THE MOST PROBABLE ROOT CAUSE IS AN INTERNAL ELECTRONIC FAILURE (SUCH AS A FAILED CIRCUIT BOARD OR POWER COMPONENT) THAT IS NOT EXTERNALLY VISIBLE. FINAL DETERMINATION REQUIRES OEM-LEVEL DIAGNOSTICS INVOLVING DETAILED ELECTRONIC TESTING AND POSSIBLY BOARD-LEVEL/COMPONENT ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED TO REPORT ERROR C-00 ON ERBE GENERATOR. AS SHE COULD NOT GIVE FURTHER DETAILS TECHNICAL SUPPORT ENGINEER (TSE) ASKED FOR CONTACT TO THE USE. NURSE DESCRIBED THAT C-00 APPEARS EVERY TIME THE ERBE IS STARTED BUT THEN DISAPPEARS AND ERBE IS USED SUCCESSFULLY NOT RELATED TO A SINGLE PROCEDURE. THE PROCEDURE HAD NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458738 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1