BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24031965 · Received January 12, 2026

    Report

    Report Number
    2955842-2026-01047
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 23, 2025
    Report Date
    January 23, 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
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND WAS CONFIRMED USING LOG REVIEWS; C-30 ERROR WAS IN THE LOGS. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE ERBE UNIT WAS TESTED USING THE SYSTEM AND SUCCESSFULLY ENERGIZED AND CAUTERIZED ALL PORTS AND INSTRUMENTS WITHOUT ANY ISSUES. A REVIEW OF THE ERBE INTERNAL LOG ALSO REVEALED ERROR C-00. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING INFORMATION: THE GENERATOR WAS REBOOTED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT ERROR C-30 OCCURRED ON VIO DV INTEGRATED ELECTROSURGICAL UNIT (IESU). THE CUSTOMER POWER CYCLED THE IESU, BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94206 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-44 N/A 00886874110898

    Patients

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