BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 18188172 · Received November 21, 2023

    Report

    Report Number
    2955842-2023-20515
    Event Type
    Death
    Date Received
    November 21, 2023
    Date of Event
    September 15, 2023
    Report Date
    September 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
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VERIFICATION OF THE EVENT DETAILS AND REVIEW OF SYSTEM AND INSTRUMENT LOGS CANNOT BE PERFORMED BECAUSE THE SITE DID NOT HAVE DA VINCI ONSITE INTERNET CONNECTIVITY AT THE TIME OF THE PROCEDURE. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT THE LIMITED INFORMATION INDICATES THE PATIENT EXPERIENCED A CARDIAC EVENT DURING A PROSTATECTOMY. THE PATIENT HAD A PRE-EXISTING HISTORY OF HYPERTENSION WHICH MAY HAVE CONTRIBUTED TO THE CARDIAC EVENT. THERE IS NO ALLEGATION OF ANY ISSUES OR PROBLEMS WITH ANY INTUITIVE PRODUCTS OR INSTRUMENTS. BASED ON THE INFORMATION PROVIDED, NO INTUITIVE SURGICAL PRODUCT CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE PATIENT EXPIRED. MID-PROCEDURE, WHILE THE SURGEON WAS APPLYING HEM-O-LOK CLIPS TO UNSPECIFIED VESSELS, THE PATIENT EXPERIENCED AN "ANESTHETIC RELATED EMERGENCY" - LATER CLARIFIED AS CARDIAC ARRHYTHMIA. NO TISSUES OR VESSELS WERE DAMAGED DURING THE EVENT AND NO BLEEDING WAS REPORTED. THE PROCEDURE WAS ABORTED WITH EMERGENCY UNDOCKING OF THE PATIENT SIDE CART AND THE ROBOTIC EQUIPMENT WAS REMOVED FROM THE OPERATING ROOM. CARDIOPULMONARY RESUSCITATION AND OTHER EXTENSIVE LIFE-SAVING MEASURES WERE ADMINISTERED FOR AN EXTENDED PERIOD OF TIME, INCLUDING PLACEMENT OF A FEMORAL LINE BY THE CARDIAC SURGICAL TEAM TO CONNECT THE PATIENT TO CARDIOPULMONARY BYPASS. THE DISTRIBUTOR REPRESENTATIVES WERE INFORMED AT A LATER DATE THAT THE PATIENT EXPIRED IN THE ICU THAT SAME EVENING. ACCORDING TO THE DISTRIBUTOR, THE SURGEONS BELIEVED THAT THE EVENT WAS NOT DUE TO AN ISSUE WITH THE DA VINCI SYSTEM OR INSTRUMENTS. NO DEVICE MALFUNCTION WAS NOTED DURING OR PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744132 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-33 N/A 00886874110720

    Patients

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