BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20328559 · Received September 27, 2024

    Report

    Report Number
    2955842-2024-19844
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 4, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 THE IESU ASSOCIATED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE IESU WAS ANALYZED, BUT THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. MULTIPLE C-00 ERRORS WERE FOUND IN ERROR LOGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE ERBE GENERATOR HAD ERRORS. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED 25913 (C-01) ERRORS ON THE ERBE GENERATOR. THE TSE WALKED THE CUSTOMER THROUGH POWER CYCLING THE GENERATOR AND DISCONNECTING THE GENERATOR'S EXTERNAL FOOT PEDALS. THE GENERATOR CAME BACK UP WITH A U-02 ERROR. THE TSE INFORMED THE CUSTOMER THAT THE LOCAL FIELD SERVICE ENGINEER WOULD NEED TO BE DISPATCHED FOR ADDITIONAL TROUBLESHOOTING. THE CUSTOMER PLACED THE CALL ON HOLD AS THEY LOCATED A THIRD-PARTY ESU DEVICE TO CONNECT BUT THE CALL WAS DROPPED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND GATHERED THE FOLLOWING INFORMATION: THE SURGEON DECIDED TO CONVERT TO LAPAROSCOPIC SURGERY BECAUSE THE ERBE GENERATOR WAS NOT WORKING. THE ERBE GENERATOR WAS NOT DELIVERING ENERGY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2603179 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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