BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS)

    MDR report key: 1706590 · Received May 18, 2010

    Report

    Report Number
    3004962788-2010-00017
    Event Type
    Malfunction
    Date Received
    May 18, 2010
    Date of Event
    April 19, 2010
    Report Date
    May 18, 2010
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPERDIMENSION REP WENT TO THE SITE TO EVALUATE THE SYS AND COULD NOT REPRODUCE THE ISSUES THAT WERE SEEN. THE THREE LOCATABLE GUIDE COMPONENTS WERE RETURNED TO SUPERDIMENSION FOR ANALYSIS. THE ANALYSIS OF ALL THREE LOCATABLE GUIDES SHOWED NORMAL FUNCTION AND NO ABNORMALITIES WERE FOUND. THE SITE PERFORMED TWO SUCCESSFUL CASES ON (B)(4)-2010 AND NO SIMILAR ISSUES WERE ENCOUNTERED. THE CASE WAS NOT COMPLETED WITH THE SUPERDIMENSION SYS WITH THE PT UNDER GENERAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PT, BUT IN AN ABUNDANCE OF CAUTION WE ARE FILING THIS MDR BECAUSE OF THE ADD'L RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE SUPERDIMENSION SYS WAS UNABLE TO REGISTER THE PT. IT WAS REPORTED THAT THE SITE COULD NOT GET THE LOCATABLE GUIDE TO SHOW UP AS A GREEN DOT ON THE SCREEN, THEY SWAPPED TO A SECOND LOCATABLE GUIDE AND ENCOUNTERED THE SAME ISSUE. THEY REPLACED THE LOCATABLE GUIDE CABLE WITH NO CHANGE. FINALLY THE THIRD LOCATABLE GUIDE WAS USED AND THIS ONE FLICKERED BETWEEN YELLOW AND GREEN. THE SUPERDIMENSION PORTION OF THE CASE WAS THEN ABORTED WITH THE PT UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1