BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1610777 · Received January 25, 2010

    Report

    Report Number
    3004659744-2010-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2010
    Date of Event
    October 28, 2009
    Report Date
    January 25, 2010
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAS SINCE PERFORMED MANY CASES AFTER THE MIDDLE OF NOVEMBER AND HAS NOT EXPERIENCED THIS SAME ISSUE. AT THIS TIME, NO FURTHER ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    THE PHYSICIAN EXPERIENCED WHAT HE CALLED "DRIFT" AFTER REGISTRATION. AS HE NAVIGATED TO THE LESION, HE FELT THE ACCURACY DRIFTED OR CHANGED. HE PULLED BACK TO THE MAIN-CARINA AND THE VISUAL VERIFICATION WAS OFF, CAUSING HIM TO RE-REGISTER. AFTER RE-REGISTERING, THE SYSTEM WAS ACCURATE AND HE COMPLETED NAVIGATION WITHOUT ISSUE. 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, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1