BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21724686 · Received March 28, 2025

    Report

    Report Number
    2955842-2025-11855
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    March 7, 2025
    Report Date
    March 7, 2025
    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
    MI, US
    Reporter Occupation
    NURSE
    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 ELECTROSURGICAL UNIT (IESU) OR ERBE. 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 ERBE WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE (ERBE U-02 ERRORS) WAS CONFIRMED AND REPRODUCED. SYSTEM LOGS FOUND ERRORS 25913 U-02 ERRORS CONFIRMING THE FAULT OCCURRED IN THE FIELD. A VISUAL INSPECTION FOUND SCRATCHES ON THE SIDE OF COVER. THE U-02 ERRORS OCCURRED DURING START-UP. THE ERBE WAS PLACED ON A SYSTEM AND WAS RUN IN NORMAL MODE. NO COMMUNICATION WITH SYSCHECKMASTER WAS FOUND TO BE THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, ERROR U-02 OCCURRED ON VIO DV INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). TSE CONFIRMED ERROR U-02 IN THE LOGS. BEFORE THE PHONE CALL, THE CUSTOMER HAD USED A BACKUP ESU TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579861 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-38 N/A 00886874110898

    Patients

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