BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1358018 · Received March 3, 2009

    Report

    Report Number
    3004962788-2009-00009
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    February 2, 2009
    Report Date
    March 2, 2009
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER): THE LOCATABLE GUIDE WAS REPLACED AND WILL BE RETURNED FOR ANALYSIS. AT THIS TIME, SUPERDIMENSION HAS NOT YET RECEIVED AND OR PROCESSED THE RETURN. IT WAS REPORTED THAT THE SITE HAS PERFORMED AT LEAST 3 MORE CASES AND ALL THE CASES WERE SUCCESSFULLY PERFORMED WITH NO ISSUES.

    Description of Event or Problem · 1

    THE USER ALLEGED THAT WHILE USING THE SYSTEM, THERE WAS AN INACCURACY ISSUE. THE USER REPORTED THAT THE REGISTRATION RECEIVED WAS 3.9 (THE SPECIFICATION IS <10). HOWEVER, THE LG DID NOT APPEAR TO BE IN THE AIRWAY. AFTER TROUBLESHOOTING THE ISSUE, THE LOCATABLE GUIDE WAS REPLACED. A 2.4 REGISTRATION RESULT WAS RECEIVED AND THE LG APPEARED TO BE IN THE AIRWAY. THE CASE WAS COMPLETED 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 INC.

    Patients

    Seq Age Sex Outcome Treatment
    1