BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2231064 · Received September 1, 2011

    Report

    Report Number
    3004962788-2011-00044
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    September 1, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPONENTS OF THE SYSTEM, THE THREE LOCATABLE GUIDES, ARE PENDING RETURN FOR ANALYSIS. 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 DURING A PROCEDURE THEY ATTEMPTED TO USE A LOCATABLE GUIDE AND THE SYSTEM GAVE A MESSAGE "THE LOCATABLE GUIDE HAS ALREADY BEEN USED. PLEASE REPLACE IT WITH AN UNUSED ONE". THEY REPLACED IT WITH A SECOND AND THIRD LOCATABLE GUIDE BUT THE SITUATION WAS THE SAME. THEREFORE, THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELLED WITH THE PATIENT UNDER GENERAL ANESTHESIA. THE CASE WAS COMPLETED FOR THE PATIENT USING OTHER METHODS AND THERE WERE NO PATIENT ISSUES AS A RESULT OF THIS ISSUE.

    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