BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17848853 · Received September 29, 2023

    Report

    Report Number
    2955842-2023-18876
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    September 7, 2023
    Report Date
    September 7, 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
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CONVERSION WAS BLEEDING. THE SURGEON MADE A DECISION TO CONVERT TO OPEN IN ORDER TO ACHIEVE HEMOSTASIS. NO INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN IMPLICATED OR RETURNED FOR FAILURE ANALYSIS (FA). 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 BY THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) THAT DURING A DA VINCI ASSISTED RECTOPEXY REVISION, THERE WAS VENOUS BLEEDING IN WHICH THE SURGEON FELT MORE COMFORTABLE ADDRESSING BY CONVERTING THE PROCEDURE TO OPEN. THERE WAS NO PARTICULAR SURGICAL TASK THAT INITIATED THE BLEEDING, AND IT WAS REPORTED THAT THERE WAS NO MALFUNCTION OF A DA VINCI PRODUCT THAT PROMPTED THE CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271953 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

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