BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS)

    MDR report key: 1722240 · Received June 3, 2010

    Report

    Report Number
    3004962788-2010-00020
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    May 7, 2010
    Report Date
    June 3, 2010
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPERDIMENSION REPRESENTATIVE WENT TO THE SITE ON (B)(4) 2010 TO EVALUATE THE SYSTEM. ACCURACY AND ENVIRONMENTAL TESTS WERE PERFORMED AND PASSED. THE SYSTEM FUNCTION WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE INITIAL NAVIGATION WAS GOOD. HOWEVER, WHEN THEY SWITCHED TO LYMPH NODE MODE, IT APPEARED THAT THE LOCATABLE GUIDE SHIFTED IN ACCURACY. THEY COULD SEE ON THE MAIN BRONCHOSCOPY IMAGE WHERE THEIR LOCATION WAS BUT THE SYSTEM IMAGE WHERE THEIR LOCATION WAS BUT THE SYSTEM DID NOT SHOW THE SAME POSITION, IT APPEARED 2+CM AWAY. IT IS IMPORTANT TO NOTE THAT THE CASE WAS COMPLETED FOR THE PERIPHERAL LESION BUT THE SHIFT IN THE VISUAL VERIFICATION WOULD NOT ALLOW FOR LYMPH NODE SAMPLING. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PATIENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1