BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM

    MDR report key: 2132838 · Received June 17, 2011

    Report

    Report Number
    3004659744-2011-00004
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 17, 2011
    Manufacturer
    SUPERDIMENSION LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SITE VISIT WAS PERFORMED ON (B)(4) 2011. THE PLANNING OF THE CASE WAS REVIEWED AND IT WAS FOUND THAT THE CT USED IN THE CASE WAS NOT MADE TO SPECIFICATIONS OUTLINED IN THE SUPERDIMENSION USER MANUAL AND WAS OF POOR QUALITY. IN ADDITION, IT WAS FOUND THAT THE LOCATION BOARD WAS NOT IN THE CORRECT POSITION. AFTER REPOSITIONING THE LOCATION BOARD, THE SYSTEM PASSED ALL TESTS AND FUNCTIONED NORMALLY. IN ADDITION, A COMPONENT OF THE SYSTEM, THE LOCATABLE GUIDE CABLE, WAS FOUND TO HAVE PINS BENT IN THE CONNECTOR. THEREFORE, THE CABLE WAS REPLACED. THE PHYSICIAN PERFORMED A CASE ON (B)(6) 2011 AND REPORTED THAT THE CASE WAS COMPLETED AND THE SYSTEM PERFORMED CORRECTLY. THERE WAS NO HARM OR INJURY TO THE PATIENT REPORTED, BUT IN AN ABUNDANCE OF CAUTION WE ARE FILING THIS MDR BECAUSE OF THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE HAD A CASE IN WHICH THEY WERE UNABLE TO GET THE PATIENT REGISTERED. IT WAS REPORTED THAT THE PHYSICIAN WAS NOT ABLE TO MARK ALL THE REGISTRATION POINTS AND THE SYSTEM DID NOT CALCULATE THE REGISTRATION WHEN REQUESTED. AS A RESULT, VERIFICATION AND NAVIGATION WERE NOT POSSIBLE. THE PHYSICIAN CHANGED THE LOCATABLE GUIDE CABLE BUT THIS DID NOT SOLVE THE REPORTED ISSUE. THEREFORE, THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE CASE WAS COMPLETED USING OTHER METHODS. THERE WAS NO HARM OR INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) JAK SUPERDIMENSION LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1