BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1678004 · Received May 6, 2010

    Report

    Report Number
    3004659744-2010-00005
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    April 9, 2010
    Report Date
    May 6, 2010
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPERDIMENSION REP WENT TO THE SITE TO EVALUATE THE SYSTEM AND THE SYSTEM FUNCTION WAS NORMAL. IT WAS DETERMINED THAT THE PT SENSOR TRIPLET WAS OUTSIDE OF THE SENSING VOLUME. CURRENT LABELING STATES: THE PT SENSOR'S SENSING VOLUME IS A VOLUME ABOVE THE LOCATION BOARD IN WHICH THE PT SENSORS WILL PERFORM PROPERLY. WHEN ONE OR MORE OF THE PT SENSORS ARE OUTSIDE THIS VOLUME, AN ON-SCREEN ALERT APPEARS, AND THE PT SENSOR ACCURACY IS NOT GUARANTEED. IN SUCH A CASE, PT SETUP CANNOT BE COMPLETED AND THE SYSTEM WILL DISABLE THE NAVIGATION FUNCTIONS. THE WORKING VOLUME FOR THE PT SENSORS START AT 50MM FROM THE LOCATION BOARD'S SURFACE AND EXTENDS UP TO 380MM. THE CASE WAS NOT COMPLETED WITH THE SUPERDIMENSION SYSTEM WITH THE PT UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PT, BUT IN AN ABUNDANCE OF CAUTION WE ARE FILING THIS MDR BECAUSE OF THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE SUPERDIMENSION SYSTEM WAS UNABLE TO REGISTER THE PT. IT WAS REPORTED THAT THE SITE REPLACED VARIOUS CABLES AND THE LOCATABLE GUIDE, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE SUPERDIMENSION PORTION OF THE CASE WAS ABORTED AND SITE USED OTHER METHODS TO COMPLETE THE CASE.

    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