BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1327614 · Received February 11, 2009

    Report

    Report Number
    3004962788-2009-00003
    Event Type
    Malfunction
    Date Received
    February 11, 2009
    Date of Event
    December 29, 2008
    Report Date
    February 11, 2009
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    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 WITH A GOOD REGISTRATION RESULTS (3MM) THE VERIFICATION FOR THE RIGHT UPPER LOBE AND LEFT UPPER LOBE IS NOT PRECISE. THE MC LOOKS PRECISE FOR THE VERIFICATION. THE NAVIGATION TO THE TARGET LOOKS OK ON THE SUPERDIMENSION SYSTEM BUT WHEN DOUBLE CHECKING WITH THE X-RAY IT SHOWS THAT WE ARE NOT AT THE TARGET. THE PHYSICIAN DECIDED TO CANCEL THE PROCEDURE. THE PROCEDURE WAS DONE UNDER FULL ANESTHESIA. 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 *