BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1294983 · Received October 28, 2008

    Report

    Report Number
    3004962788-2008-00022
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 28, 2008
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGED THAT WHILE USING THE SYSTEM THERE ARE CONSISTENT INACCURACY ISSUES OF 1- 3CM. THE USER REPORTED THAT THEY NAVIGATED TO WHERE THE SYSTEM WOULD TELL THEM TO AND WOULD TAKE A BIOPSY. THE ON-SITE PATHOLOGY REPORTED NORMAL CELLS. THE PHYSICIAN THEN MOVED THE LG TIP 1- 3CM AND TOOK A NEW BIOPSY AND RECEIVED AN ABNORMAL PATHOLOGY RESULT. THEY WERE UNABLE TO COMPLETE THE CASE AND 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 *