BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 18165494 · Received November 17, 2023

    Report

    Report Number
    2955842-2023-20422
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 31, 2023
    Report Date
    October 31, 2023
    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
    AZ, US
    Reporter Occupation
    003

    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 ISI FSE WAS ABLE TO REPRODUCE THE REPORTED ISSUE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. ISI HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    FAILURE ANALYSIS (FA) HAS COMPLETED THEIR INVESTIGATION ON THE VIO INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU). FA WAS ABLE TO REPRODUCE THE ISSUE BY PLACING THE UNIT ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE SITE WAS EXPERIENCING C-34 ERROR ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE ISI TSE VIEWED LOGS AND CONFIRMED THE ERROR. THE ISI CSR STATED THAT THE SITE TRIED NEW ENERGY CORDS AND INSTRUMENTS WITH NO CHANGE. THE ISI CSR STATED THAT THE SITE ALSO TRIED TO RESTART THE IESU WITH NO CHANGE. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744569 DA VINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-10 N/A 00886874110898

    Patients

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