BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 19994308 · Received August 15, 2024

    Report

    Report Number
    2955842-2024-18214
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    July 18, 2024
    Report Date
    July 18, 2024
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS BEEN IMPLICATED OR RETURNED FOR FAILURE ANALYSIS (FA) INVESTIGATION. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED ABDOMINOPERINEAL RESECTION, AN UNKNOWN EVENT CAUSED A TEAR IN THE ILIAC ARTERY WHICH REQUIRED AN EMERGENT CONVERSION TO OPEN TO ACHIEVE HEMOSTASIS. THE VASCULAR TEAM REPAIRED THE ARTERY WITH A GRAFT. IT WAS REPORTED THAT THE PATIENT RECEIVED A BLOOD TRANSFUSION, BUT IT IS UNKNOWN HOW MANY. THE PATIENT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896355 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| L DA VINCI INSTRUMENTS AND ACCESSORIES