BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLUMISITE

    MDR report key: 11372100 · Received February 24, 2021

    Report

    Report Number
    11372100
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 25, 2021
    Report Date
    January 25, 2021
    Manufacturer
    COVIDIEN
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NAVIGATION REGISTRATION COMPLETED UNEVENTFULLY. DURING BIOPSY ATTEMPTS, RECEIVED "RECONNECT LOCATABLE GUIDE" ERROR MESSAGE. ERROR DISAPPEARED WHEN LG UNLOCKED, REAPPEARED WHEN LG RELOCKED. FURTHER ATTEMPTS TO CONTINUE NAVIGATION WOULD NOT WORK BECAUSE EMN ESTIMATED POSITION OF LG BEGAN TO FLUCTUATE WILDLY (DISCORDANCE BETWEEN VIRTUAL BRONCHOSCOPIC VIEW WHEN LG IN EWC VS WHEN LG WAS OUT OF EWC). THERE WAS NO UNUSUAL PRESSURE OR FORCE APPLIED TO THE SCOPE OR LG DURING THE PROCEDURE. ALL CORDS WERE DISCONNECTED/RECONNECTED WITHOUT IMPROVEMENT. LG REPLACED, ERROR NO LONGER PRESENT. SUSPECT LG MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270561 ILLUMISITE SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 21535 DA