BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1354982 · Received March 16, 2009

    Report

    Report Number
    3004962788-2009-00011
    Event Type
    Malfunction
    Date Received
    March 16, 2009
    Date of Event
    February 16, 2009
    Report Date
    March 16, 2009
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGED THAT WHILE USING THE SYSTEM THERE WAS AN INACCURACY ISSUE. THE USER REPORTED THAT WHEN LOOKING AT THE FLUORO IMAGE PRIOR TO BIOPSY, IT WAS QUESTIONABLE IF THE LOCATABLE GUIDE WAS AS LATERALLY PLACED IN THE RIGHT UPPER LESION AS THE CORONAL CT INDICATED IT SHOULD BE, EVEN THOUGH THE NAVIGATION INDICATED THE PHYSICIAN WAS CLOSE TO THE LESION. THE PHYSICIAN WENT AHEAD AND TOOK BIOPSIES. AFTER THE BIOPSIES, THE PHYSICIAN DID ANOTHER VISUAL VERIFICATION WHICH INDICATED SOME INACCURACY; THE LG APPEARED IN THE RIGHT MAINSTEM BRONCHUS WHEN IT SHOULD HAVE BEEN IN THE MAIN CORINA (APPROX 1-2CM OFF). THE CASE WAS COMPLETED USING SUPERDIMENSION AND A POSITIVE DIAGNOSIS WAS RECEIVED IN SPITE OF THE ALLEGED INACCURACY. 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 *