BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION IN REACH BRONCHUS SYSTEM (SDBS)

    MDR report key: 2012252 · Received February 2, 2011

    Report

    Report Number
    3004962788-2011-00004
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 4, 2011
    Report Date
    February 2, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 IT FUNCTIONED NORMALLY. THERE IS NO INDICATION THAT THE SYSTEM MALFUNCTIONED. THERE WAS NO PATIENT INJURY. THE SITE HAS SINCE PERFORMED CASES WITH SUCCESS. 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

    A SITE REPORTED THAT DURING REGISTRATION THEY CONTINUALLY RECEIVED A MISMATCHED POINTS ERROR MESSAGE. THE SITE RECEIVED ANOTHER RECONSTRUCTION OF THE CT SCAN AND REPLANNED THE CASE. THEY ATTEMPTED MANUAL REGISTRATION 4 TIMES BUT WERE UNABLE TO REGISTER THE PATIENT AND THE CASE WAS CANCELLED 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 IN REACH BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1