BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 21084943 · Received January 6, 2025

    Report

    Report Number
    2955842-2024-23599
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    October 25, 2024
    Report Date
    December 11, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. THE D4 FIELDS ARE FOR THE PATIENT SIDE CART (PSC) AS NO ADDITIONAL INSTRUMENT INFORMATION WAS PROVIDED. EVENT VERIFICATION AND SYSTEM/INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION PROVIDED.

    Description of Event or Problem · 0

    ON (B)(6)2024, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MEDWATCH (MW)5162741 STATING: "DAVINCI ROBOTIC CLIP APPLIERS WOULD NOT CLOSE WITHIN BODY CAVITY, DISPLACING THE SURGICAL CLIP WITHIN THE BODY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417972 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-43 N/A

    Patients

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