BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17563681 · Received August 17, 2023

    Report

    Report Number
    2955842-2023-17805
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 19, 2023
    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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF VENOUS THROMBOSIS IS UNKNOWN. WHILE THE SURGEON CONFIRMS THE POST-OPERATIVE COMPLICATION IS SURGICALLY RELATED, NO INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN IMPLICATED OR RETURNED FOR FAILURE ANALYSIS (FA). ADVANCED LOGS CANNOT BE PERFORMED DUE TO CONFLICTING PROCEDURAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED PROCEDURE, THE PATIENT DEVELOPED A VENOUS THROMBOSIS. THE SURGEON MENTIONED THAT WHILE THIS WAS A SURGICAL COMPLICATION, IT WAS NOT NECESSARILY A ROBOTIC COMPLICATION. INTUITIVE SURGICAL, INC. (ISI) HAS MADE MULTIPLE UNSUCCESSFUL FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963082 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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