BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2222279 · Received August 24, 2011

    Report

    Report Number
    3004962788-2011-00042
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 24, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, A SITE VISIT WAS PERFORMED. A FUNCTIONAL TEST OF THE SYSTEM WAS PERFORMED, INCLUDING COMPONENTS OF THE SYSTEM SUCH AS THE CABLES AND THE LOCATION BOARD. THE SYSTEM PERFORMED AS DESIGNED AND NO ISSUES WERE OBSERVED. THE CONSOLE MAINTENANCE. LOG FILE WAS REVIEWED AND THE MESSAGE "ANTENNA IS NOT FUNCTION GOOD" WAS FOUND. THIS MESSAGE WAS RECORDED, SOMEWHAT INTERMITTENTLY, IN THE LOG (B)(6) 2010 WHEN THE SITE REPLACED THEIR LOCATION BOARD PIGTAIL. IT WAS GENERATED IN THE LOG AGAIN THE WEEK OF (B)(6) 2011, INTERMITTENTLY, AGAIN ASSOCIATED WITH A PIGTAIL REPLACEMENT BY THE SITE. THE PIGTAIL REPLACEMENT IS AT THE ROOT OF THE RECENT PROBLEMS WITH LB MESSAGES, IT MAY NOT HAVE BEEN SEATED ALL THE WAY WHEN FIRST INSTALLED. HOWEVER, THIS HAS SINCE BEEN RESOLVED AND IT WAS VERIFIED DURING THE SITE VISIT. ADDITIONALLY, THE DISPLAY ISSUE THAT WAS NOTED DURING THE CASE WAS CREATED AFTER THE DISPLAY OF A LOCATION BOARD ERROR MESSAGE ALONG WITH THE LOCATABLE GUIDE BEING REMOVED FROM THE SENSING VOLUME. WHEN THE LOCATABLE GUIDE IS REINTRODUCED INTO THE SENSING VOLUME, AND THERE ARE NO ADDITIONAL MESSAGES DISPLAYED, THE IMAGES ARE REFRESHED WITH FRESH VIRTUAL BRONCHOSCOPY AND LIVE VIDEO BRONCHOSCOPE IMAGES. THIS IS NORMAL DEVICE OPERATION. FINALLY, THE LOCATABLE GUIDE THAT WAS USED IN THE CASE WAS RETURNED FOR ANALYSIS AS A PRECAUTION. THE ANALYSIS OF THE LOCATABLE GUIDE CONCLUDED THAT THE DEVICE OPERATED NORMALLY AND NO ANOMALIES WERE FOUND. THERE WAS NO INJURY TO THE PATIENT REPORTED. IN AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED DUE TO THE ADDITIONAL POTENTIAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THEIR SYSTEM WAS LOCKING UP AFTER ACCEPTING REGISTRATION. THEY HAD ATTEMPTED BOTH MANUAL AND AUTOMATIC REGISTRATION BUT UPON SELECTING "ACCEPT" OR "CONTINUE TO NAVIGATION" THE SCREEN FROZE. THEY CANCELLED THE SUPERDIMENSION PORTION OF THE PROCEDURE 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 INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) JAK SUPERDIMENSION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1