BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1231056 · Received October 30, 2008

    Report

    Report Number
    3004962788-2008-00023
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 30, 2008
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CODES, (OTHER): THE TECHNICAL FIELD SPECIALIST WENT TO THE SITE TO CHECK THE SYSTEM IN 2008. IT WAS DISCOVERED THAT THE SITE WAS USING A BRONCHOSCOPE THAT IS NOT COMPATIBLE WITH THE SUPERDIMENSION SYSTEM AND CAN BE A POTENTIAL CAUSE OF THE REPORTED SYSTEM INACCURACIES. IT WAS RECOMMENDED TO THE SITE TO CHANGE THE BRONCHOSCOPE TO ONE OF THE COMPATIBLE SCOPES LISTED IN THE SUPERDIMENSION USER MANUAL. CURRENT LABELING STATES: "USE OF BRONCHOSCOPES THAT ARE NOT COMPATIBLE WITH THE SUPERDIMENSION/BRONCHUS SYSTEM MAY LEAD TO INACCURACY OF THE SYSTEM". AN ACCURACY TEST WAS PERFORMED ON THE SYSTEM AND THE RESULTS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE USER ALLEGED THAT WHILE USING THE SYSTEM, THEY WERE UNABLE TO REGISTER THE PT. THE SYSTEM WOULD ONLY GIVE "POINTS MISMATCHED" ERRORS. THE SITE REPLACED THE LOCATABLE GUIDE, LOCATABLE GUIDE CABLE AND PT SENSOR TRIPLET IN AN ATTEMPT TO REGISTER THE PT, BUT ALL ATTEMPTS WERE UNSUCCESSFUL. THE SITE WAS UNABLE TO COMPLETE THE CASE. 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 INC.

    Patients

    Seq Age Sex Outcome Treatment
    1