BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1577610 · Received January 6, 2010

    Report

    Report Number
    3004962788-2010-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2010
    Date of Event
    December 8, 2009
    Report Date
    January 6, 2010
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS PERFORMED AT THIS SITE ON (B) (6) 2009. THE ACCURACY TESTING DID NOT SHOW ANY PROBLEMS, THE TESTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SUPERDIMENSION CASE, THE PHYSICIAN LOST ACCURACY AFTER RECEIVING A GOOD REGISTRATION VALUE OF 5.3MM (CURRENT SPEC IS <10). AFTER RE-INSERTING THE LOCATABLE GUIDE AFTER TAKING BIOPSIES, THE VISUAL VERIFICATION WAS NOW OFF, IT APPEARED THAT THE LG SHIFTED INTO THE RIGHT MAIN STEM BRONCHUS WHEN THE LG WAS ACTUALLY SITTING RIGHT ON THE MAIN CARINA. THERE WAS NO HARM OR INJURY TO THE PT REPORTED.

    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