BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 20899142 · Received December 10, 2024

    Report

    Report Number
    2955842-2024-23079
    Event Type
    Death
    Date Received
    December 10, 2024
    Date of Event
    June 26, 2024
    Report Date
    November 18, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR THE DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. A REVIEW OF THE ARTICLE PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THIS ARTICLE DESCRIBES A 10 YEAR STUDY ON HEPATOBILIARY CANCERS WITH 3 DEATHS; TWO FROM CARDIAC EVENTS AND ONE FROM GI BLEED. THE DETAILS OF HOW THESE PATIENTS DIED AND THE EVENTS THAT LED TO THEIR DEMISE ARE NOT REPORTED. NO ALLEGATIONS ARE MADE AGAINST ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THESE EVENTS. CITATION: CHRISTODOULOU M, PATTILACHAN T, ROSS S, ET. AL, A SINGLE INSTITUTION¿S EXPERIENCE WITH ROBOTIC RESECTIONS OF BILIARY TRACT CANCERS: AN ANALYSIS OF THE SHORT-TERM OUTCOMES AND LONG-TERM SURVIVAL, JOURNAL OF GASTROINTESTINAL SURGERY, VOLUME 28, ISSUE 9, 2024, PAGES 1498-1504, ISSN 1091-255X HTTPS://DOI.ORG/10.1016/J.GASSUR.2024.06.021. SECTION D - SUSPECT MEDICAL DEVICE: THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, A GENERIC DAVINCI XI SYSTEM INFORMATION WAS REPORTED.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE DESCRIBED A SINGLE SITE PROSPECTIVE OBSERVATIONAL STUDY EVALUATING THE FEASIBILITY AND SAFETY OF ROBOTIC RESECTIONS FOR VARIOUS TYPES OF BILIARY TRACT CANCERS, INCLUDING PERIHILAR CHOLANGIOCARCINOMA (PCCA), INTRAHEPATIC CHOLANGIOCARCINOMA (IHCC), AND GALLBLADDER CANCER (GBC), AND ANALYZED BOTH SHORT-TERM OUTCOMES AND LONG-TERM SURVIVAL. THE STUDY OCCURRED FROM 2013 TO 2023 AND INCLUDED A TOTAL OF 100 PATIENTS. THE FIRST COHORT INCLUDED 27 PATIENTS WITH PCCA, THE SECOND COHORT COMPRISED 25 PATIENTS WITH GBC, AND THE THIRD COHORT CONSISTED OF 48 PATIENTS WITH IHCC. THE ARTICLE NOTED THREE IN-PATIENT MORTALITIES SUBSEQUENT TO POSTOPERATIVE COMPLICATIONS: TWO PATIENTS EXPIRED DUE TO MULTIORGAN SYSTEM FAILURE FROM CARDIAC EVENTS, AND ONE PATIENT EXPIRED DUE TO A GASTROINTESTINAL BLEED TREATED WITH EMBOLIZATION UNDER GENERAL ANESTHESIA. THERE WERE NO SPECIFIC DEMOGRAPHICS OR ADDITIONAL INFORMATION REGARDING THE THREE PATIENTS. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED NOR ANY ALLEGATIONS THAT DA VINCI PRODUCTS CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE; NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575323 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

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