BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2181942 · Received July 28, 2011

    Report

    Report Number
    3004962788-2011-00034
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 27, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COPY OF THE RECORDING FROM THIS CASE WAS RECEIVED FOR ANALYSIS. THERE WAS A LARGE CT-TO-BODY DIVERGENCE, ESPECIALLY A SIGNIFICANT ROTATION OF THE LEFT UPPER LOBE (LUL) AND THE LINGULA RELATIVE TO THE REST OF THE LUNGS. THE REGISTRATION ALGORITHMS WHICH ASSUME RIGID BODY REGISTRATION COULD NOT HANDLE SUCH A LARGE CT-TO-BODY DIVERGENCE. THIS MAY HAVE BEEN DUE TO A DIFFERENCE IN PATIENT BODY POSITION BETWEEN THE CT SCAN AND PROCEDURE, SUCH AS BREATH HOLD STATE OR ARMS BEING RAISED DURING THE SCAN AND AT THEIR SIDE DURING THE PROCEDURE. THE SYSTEM PERFORMED AS DESIGNED. THE PHYSICIAN COMPLETED THIS CASE USING OTHER METHODS. NOTE: A LARGE DIFFERENCE BETWEEN THE CT SCAN AND THE ACTUAL PATIENT ANATOMY DURING THE PROCEDURE IS CALLED CT-TO-BODY DIVERGENCE.

    Additional Manufacturer Narrative · 1

    A COPY OF THE RECORDING FROM THIS CASE WAS RECEIVED FOR ANALYSIS. THE ANALYSIS OF THE CASE RECORDING IS PENDING. 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. (B)(4). NO RETURN.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT AFTER ACQUIRING A SUCCESSFUL REGISTRATION, THE PHYSICIAN NAVIGATED TO THE LEFT LOWER LOBE WHERE THE LESION WAS LOCATED. WHEN THE PHYSICIAN CONFIRMED HIS LOCATION, IT WAS ACTUALLY OUT IN THE LINGULA. THE PHYSICIAN BELIEVED THE SYSTEM WAS INACCURATE. THEREFORE, THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE CASE WAS COMPLETED WITH OTHER METHODS ACCORDING TO THE SITE AND 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