BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19671696 · Received July 3, 2024

    Report

    Report Number
    2955842-2024-16471
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    June 7, 2024
    Report Date
    June 7, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN IMPLICATED OR RETURNED FOR FAILURE ANALYSIS (FA). DUE TO INSUFFICIENT PROCEDURAL INFORMATION, FURTHER SYSTEM/INSTRUMENT LOG INVESTIGATION CANNOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI ASSISTED PROCEDURE, THE STAFF CONVERTED THE PROCEDURE TO OPEN. DURING FOLLOW UP WITH THE ROBOTICS COORDINATOR (ROCO), IT WAS LEARNED THE CONVERSION WAS LIKELY DUE TO PATIENT ANATOMY ISSUES AND THERE WAS NO REPORT OF MALFUNCTION OF THE DAVINCI SYSTEM. THERE IS INSUFFICIENT INFORMATION REGARDING THE DETAILS OF THE CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271847 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-33 UNKNOWN 00886874110720

    Patients

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