BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1031577 · Received March 19, 2008

    Report

    Report Number
    3004962788-2008-00004
    Event Type
    Injury
    Date Received
    March 19, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 17, 2008
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGED THAT WHILE USING THE LG, THERE WAS AN INACCURACY ISSUE DURING THE NAVIGATION PROCESS. ON THE CROSS SECTIONS OF THE NAVIGATION SCREENS, THE TIP OF THE LG WAS OFF, ABOUT 12CM, WHEN THE ACTUAL VIDEO IMAGE SHOWED THE LG TIP PHYSICALLY TOUCHING THE MAIN CARINA. A NEW LG WAS THEN USED, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO HARM OR INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION, LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization