BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19256103 · Received May 6, 2024

    Report

    Report Number
    2955842-2024-14163
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 11, 2024
    Report Date
    April 11, 2024
    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
    CA, US
    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 INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO RESOLVE THE REPORTED 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 BUT THE REPORTED FAILURE (REPEATED C-01 ERRORS) COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. C-00/M-31 ERRORS WERE FOUND IN ERROR LOG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA BILATERAL SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT THEY ENCOUNTERED REPEATED C-01 ERRORS ON THE VIO DV 2.0 INTEGRATED ELECTROSURGICAL UNIT (ERBE). THE CUSTOMER STATED THAT THE ISSUE DID NOT RESOLVE SO THEY BROUGHT IN THE FORCE TRIAD GENERATOR. THE CUSTOMER STATED THAT AFTER CONNECTING THE FORCE TRIAD GENERATOR THE VISION SIDE CART DID NOT DETECT ENERGY. THE TSE CONFIRMED THAT THE CUSTOMER WAS USING THE CORRECT VALLEY LAB CABLE. THE CUSTOMER DECIDED TO BRING IN ANOTHER VISION SIDE CART FOR THE SURGEON TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641678 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES