BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18278983 · Received December 6, 2023

    Report

    Report Number
    2955842-2023-20856
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    December 15, 2022
    Report Date
    November 7, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT WAS NOT RECEIVED FOR FAILURE ANALYSIS EVALUATION. THERE WAS INSUFFICIENT PROCEDURAL INFORMATION TO PERFORM FURTHER ADVANCED LOG INVESTIGATION(S). .

    Description of Event or Problem · 0

    ON 07-NOV-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED USER FACILITY REPORT 2100090000-2023-8008 STATING: "LOSS OF SPATIAL ORIENTATION AND VISUAL CUES IN THE SETTING OF NORMAL BILATERAL OVARIAN ANATOMY LED TO THE REMOVAL OF THE UNINTENDED OVARY. SUGGESTION: EXPLORE THE FEASIBILITY OF ADDING RIGHT AND LEFT ON THE SCREEN WITHIN THE CONSOLE OF ROBOTIC SURGICAL EQUIPMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199751 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES