BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTUITIVE ION ROBOTIC BRONCHOSCOPY

    MDR report key: 20181116 · Received September 9, 2024

    Report

    Report Number
    MW5159362
    Event Type
    Death
    Date Received
    September 9, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    EOQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 78 YO F POST ION ROBOTIC BRONCHOSCOPY. NO REPORTED COMPLICATIONS DURING PROCEDURE. POST PROCEDURE PATIENT WAS UNAROUSABLE, AND A CODE STROKE INITIATED. IMAGING NEGATIVE. PATIENT WAS TRANSFERRED TO THE ICU(INTENSIVE CARE UNIT) FOR ADDITIONAL MANAGEMENT AND TREATMENT. ULTIMATELY TRANSITIONED TO HOSPICE. MULTIPLE RECENT SMALL INFARCTS INCLUDING THE LEFT BASAL GANGLIA AND RIGHT MEDIAL OCCIPITAL LOBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297938 INTUITIVE ION ROBOTIC BRONCHOSCOPY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ INTUITIVE SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death