BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1239269 · Received October 8, 2008

    Report

    Report Number
    3004962788-2008-00020
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 8, 2008
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGED THAT WHILE USING THE SYSTEM, THERE ARE CONSISTANT INACCURACY ISSUES OF 1-3CM. THE USER REPORTED THAT WHEN PROCEEDING TO NAVIGATION THE SCREEN SHOWS THE LOCATABLE GUIDE WELL OUTSIDE OF THE AIRWAY DESPITE BEING IN THE LARGE MAIN BRONCHUS. THE PHYSICIAN DECIDED TO CANCEL THE PROCEDURE. THERE WAS 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 *