BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2080611 · Received May 6, 2011

    Report

    Report Number
    3004962788-2011-00021
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPONENT OF THE SYSTEM, THE LOCATABLE GUIDE, WAS RETURNED FOR ANALYSIS. THE EVALUATION OF THE LOCATABLE GUIDE DETERMINED THAT ONE OF THE COILS HAD A BREAK IN THE WIRE. IN ADDITION, THE EVENT LOGS FROM THE PROCEDURE WERE RETURNED AND REVIEWED AND IT WAS DETERMINED THAT THE LOCATION BOARD WAS DISCONNECTED AND CONNECTED AT THREE DIFFERENT TIMES DURING THE PROCEDURE. BASED ON THE COMPLAINT INFORMATION, THIS DID NOT APPEAR TO BE INTENTIONAL. THEREFORE, IN AN ABUNDANCE OF CAUTION, SOME COMPONENTS OF THE SYSTEM (THE LOCATION BOARD CABLE AND LOCATION BOARD CABLE TAIL) WERE SENT FOR REPLACEMENT AS A PRECAUTION. THE FIRST BIOPSY WAS SUCCESSFUL. THE PHYSICIAN REACHED THE SECOND LESION BUT HAD DIFFICULTY WITH NAVIGATION AND THE CASE WAS DISCONTINUED. 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 AFTER SUCCESSFULLY NAVIGATING TO THE FIRST LESION AND OBTAINING SAMPLES, THEY HAD NAVIGATION DIFFICULTIES AND WERE UNABLE TO SAMPLE THE SECOND TARGET. DURING THE NAVIGATION TO THE 2ND LESION, THEY WERE ABLE TO GET WITHIN 1-2CM BUT WERE UNABLE TO GET ALL THE WAY TO THE LESION. THE PHYSICIAN RENAVIGATED AND WAS WITHIN 4-5CM OF THE LESION, HOWEVER, THE SYSTEM WAS REGISTERING THE LOCATABLE GUIDE (LG) AS BEING OUT OF THE SENSING VOLUME. THE PHYSICIAN WENT TO THE ADVANCED SCREEN BUT COULD NOT GET THE LG TIP TO APPEAR, EVEN WHEN THEY WITHDREW IT TO THE CENTRAL AIRWAY. THEREFORE, THE PHYSICIAN DECIDED NOT TO CONTINUE NAVIGATING TO THE SECOND LESION AND DISCONTINUED THE REST OF THE PROCEDURE WITH THE PATIENT UNDER GENERAL ANESTHESIA. 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