BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 25068026 · Received May 4, 2026

    Report

    Report Number
    2955842-2026-23768
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 5, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: G3, G6, H2, H6, H11. CORRECTED FIELDS: H6, H11. ADDITIONAL INFORMATION: FURTHER INVESTIGATION REVEALED THAT THE PATIENT UNDERWENT AT LEAST SIX ROUNDS OF CARDIOPULMONARY RESUSCITATION (CPR) FOLLOWING THE CONVERSION. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO INTERVENTIONAL RADIOLOGY FOR MANAGEMENT OF THE BLEEDING. THE PATIENT WAS REPORTED TO BE AWAKE IN THE INTENSIVE CARE UNIT (ICU) BEFORE BEING TRANSFERRED TO THE WARD. IT WAS DETERMINED THAT NO INTUITIVE PRODUCT, INSTRUMENT, OR SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED BLEEDING EVENT. THERE HAS BEEN NO ADDITIONAL INFORMATION REGARDING WHEN THE PROCEDURE WILL BE PERFORMED OR COMPLETED.

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT OF ANY MALFUNCTION OF AN INTUITIVE SURGICAL INC. (ISI) SYSTEM, INSTRUMENT OR ACCESSORY OCCURRING DURING THE PROCEDURE; THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SINGLE PORT (SP) DA VINCI-ASSISTED TRANS-ORAL MALIGNANT TONGUE BASE RESECTION PROCEDURE, DURING TUMOR DISSECTION, THE CAROTID ARTERY WAS INADVERTENTLY INJURED WITH AN UNSPECIFIED ENERGY INSTRUMENT. THE BLOOD LOSS VOLUME REMAINS UNKNOWN; HOWEVER, THE PATIENT REQUIRED A BLOOD TRANSFUSION. INITIAL HEMOSTASIS EFFORTS INCLUDED SUCTIONING AND NEURO SPONGE APPLICATION. THE BLEEDING COULD NOT BE MANAGED BY SUCTION ALONE, SO AN EMERGENCY UNDOCK WAS PERFORMED. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO INTERVENTIONAL RADIOLOGY, WHERE A VASCULAR SURGEON ACHIEVED HEMOSTASIS BY AN UNSPECIFIED METHOD. THE PROCEDURE WAS PROLONGED BY GREATER THAN 30 MINUTES AND WAS NOT COMPLETED; THE PATIENT WAS LAST REPORTED AWAKE IN THE INTENSIVE CARE UNIT (ICU).

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54168 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-51 N/A 00886874114605

    Patients

    Seq Age Sex Outcome Treatment
    1