BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2132637 · Received June 17, 2011

    Report

    Report Number
    3004962788-2011-00030
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 17, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SITE VISIT WAS COMPLETED ON (B)(6) 2011. THE SYSTEM PERFORMED AS DESIGNED AND NO ISSUES WERE OBSERVED. IN ADDITION, THE SITE HAS PERFORMED SEVERAL SUCCESSFUL CASES AFTER THIS CASE AND THERE HAVE BEEN NO ADDITIONAL ISSUES. THERE WERE NO PROCEDURE RECORDINGS AVAILABLE TO REVIEW BECAUSE THE RECORDINGS DO NOT BEGIN UNTIL REGISTRATION IS COMPLETE. IN ADDITION, THE MESSAGE THE USER ENCOUNTERED IS LISTED IN THE CURRENT USER MANUAL. 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. NO RETURN.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THEY HAD TO MANUALLY REGISTER THE PATIENT. AFTERWARDS, WHEN THEY TOUCHED ALL THE REGISTRATION POINTS, THE SYSTEM KEPT GIVING THEM A MESSAGE THAT STATED THAT THE POINTS DIDN'T MATCH. IT WAS REPORTED THAT THE SITE TRIED MULTIPLE TIMES TO REGISTER THE PATIENT AND EVEN RESTARTED THE SYSTEM. UNFORTUNATELY, THEY WERE NOT ABLE TO GET THE PATIENT REGISTERED AND CHOSE TO ABORT THE SUPERDIMENSION PORTION OF THE CASE WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE CASE WAS COMPLETED USING OTHER METHODS.

    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