BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21256692 · Received January 28, 2025

    Report

    Report Number
    2955842-2025-00912
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    January 6, 2025
    Report Date
    January 6, 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
    NH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD (DHR) REVIEW FOR ERBE INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. THE PROBABLE ROOT CAUSE OF THIS ISSUE IS ATTRIBUTED TO ERROR MESSAGES/FAULTS ON THE ON THE ERBE INTEGRATED ELECTRO SURGICAL UNIT (IESU).

    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 GENERATOR 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 BUT THE REPORTED FAILURE (ISSUES WHEN CUTTING) COULD NOT BE REPRODUCED ON ERBE CONNECTED TO SYSTEM. LOGS SHOWED (25913 U-04 ERRORS 1/06/2025.) VISUAL INSPECTION: (THE UNIT HAS NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL IS IN DECENT CONDITION.) THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS ON SYSTEM. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE WAS ATTRIBUTED TO ELECTRICAL DEFECT OF THE IESU (U-04 ERROR).

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS NOT WORKING AND THE SITE SWITCHED OVER TO THE EXTERNAL FORCE TRIAD GENERATOR. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) DETERMINED THAT THE CUSTOMER HAD CONNECTED A THIRD-PARTY COVIDIEN FT-10 GENERATOR AND ADVISED HER THAT THIS GENERATOR WAS NOT VALIDATED FOR USE AS AN ALTERNATE GENERATOR WITH THE DA VINCI SURGICAL SYSTEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240369 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

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