BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1509333 · Received October 1, 2009

    Report

    Report Number
    3004659744-2009-00029
    Event Type
    Malfunction
    Date Received
    October 1, 2009
    Date of Event
    September 2, 2009
    Report Date
    October 1, 2009
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT THE SITE HAS PERFORMED AT LEAST 5 CASES SINCE THIS CASE AND THERE HAVE BEEN NO PROBLEMS REPORTED. THE PHYSICIAN FROM THIS CASE HAS PERFORMED TWO OF THE FIVE CASES WITH NO ISSUES. THERE ARE NO FURTHER ACTIONS REQUIRED AT THIS TIME. THE PROCEDURE IS TYPICALLY PERFORMED UNDER LOCAL ANESTHESIA. HOWEVER, BASED ON THE ERROR MESSAGES PROVIDED BY THE SYSTEM, THE PROCEDURE WAS DISCONTINUED, BY THE PHYSICIAN, WITH THE PT UNDER GENERAL ANESTHESIA. IN AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED DUE TO THE ADDITIONAL POTENTIAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA. THERE WAS NO INJURY TO THE PT REPORTED.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO REGISTER THE PT 10-15 TIMES AND WAS NOT SUCCESSFUL. HE WAS NOT ABLE TO GET THE REGISTRATION VALUE BELOW 13MM (CURRENT SPEC IS <10) AND RECEIVED AN ERROR MESSAGE TO REQUIRE ALL POINTS. THE SITE SWAPPED CABLES AND THE LOCATABLE GUIDE, BUT THIS DID NOT HELP, THEY CONTINUED TO RECEIVE THE ERROR MESSAGE. THEREFORE, THE PROCEDURE WAS CANCELLED. 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, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1