BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18449152 · Received January 4, 2024

    Report

    Report Number
    2955842-2023-21856
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    December 8, 2023
    Report Date
    December 8, 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
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN IMPLICATED OR RETURNED FOR FAILURE ANALYSIS (FA). ADVANCED ENERGY LOGS SHOW THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS INSTALLED TWICE AND PASSED HOMING EACH TIME. THERE WERE 55 CUT COMPLETE EVENTS WITH NO ERRORS. E100 LOGS SHOW 1 COAGULATION EVENT WITH NO ERRORS. 84 SEAL EVENTS WERE RECORDED, WITH 1 HIGH INITIAL STARTING IMPEDANCE ERROR. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED LOWER ANTERIOR RESECTION, THE PROCEDURE WAS CONVERTED TO OPEN DUE TO BLEEDING. THE CAUSE OF THE BLEEDING IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587130 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-41 N/A 00886874110720

    Patients

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