BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18494154 · Received January 11, 2024

    Report

    Report Number
    2955842-2023-22011
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    December 15, 2023
    Report Date
    December 15, 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
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY DUE TO THE SURGEON NEEDING BETTER ACCESS INSIDE THE PATIENT'S ANATOMY. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER ELECTED TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY DUE TO AN ISSUE NOT RELATED TO THE DA VINCI SYSTEM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO THE PROCEDURE BEING MORE INVOLVED AND THE CUSTOMER NEEDED BETTER ACCESS FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888405 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES