BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2080228 · Received May 6, 2011

    Report

    Report Number
    3004962788-2011-00020
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 6, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPONENT OF THE SYSTEM, THE LOCATION BOARD CABLE TAIL, WAS REPLACED. THE LOCATION BOARD CABLE TAIL WAS RETURNED FOR ANALYSIS. THE EVALUATION OF THE LOCATION BOARD CABLE TAIL DETERMINED THAT ALL 6 CONDUCTOR WIRES IN THE CABLE WERE BROKEN AT THE CONNECTOR. THIS TYPE OF DAMAGE INDICATES THAT SOME TYPE OF EXCESSIVE FORCE HAD BEEN APPLIED TO THE LOCATION BOARD CABLE TAIL. 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 WHEN ATTEMPTING TO SET UP FOR A PROCEDURE, THEY COULD NOT CONNECT TO THE LOCATION BOARD (LB). THE SITE SWAPPED FOR THE SPARE LOCATION BOARD CABLE AND TRIED RESETTING THE LOCATION SUBSYSTEM WITH NO CHANGE. THE SITE WAS ABLE TO MANIPULATE THE LOCATION BOARD CABLE TAIL AND GET A MOMENTARY CONNECTION BUT NOT ENOUGH TO PERFORM THE CASE. THEREFORE, THE SUPERDIMENSION PORTION OF THE CASE WAS CANCELED WITH THE PATIENT ALREADY UNDER GENERAL ANESTHESIA.

    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