BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19858412 · Received July 30, 2024

    Report

    Report Number
    2955842-2024-17309
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 2, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. FSE REPLACED INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS NOT RECEIVED THE DEVICE FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE REPORTED FAILURE WAS CONFIRMED AND REPRODUCED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A NURSE CALLED AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT 4-71 ERROR ON INTEGRATED ELECTROSURGICAL UNIT (IESU). THE IESU WAS POWER CYCLED, BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM, ADVERSE OUTCOME OR INJURY. THE ISSUE CAUSED A DELAY OF LESS THAN 15 MINUTES.

    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
    200604 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-29 N/A

    Patients

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