BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS)

    MDR report key: 1708841 · Received June 1, 2010

    Report

    Report Number
    3004962788-2010-00018
    Event Type
    Malfunction
    Date Received
    June 1, 2010
    Date of Event
    May 3, 2010
    Report Date
    June 1, 2010
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN SELECTED A CENTRALLY LOCATED LESION AND AN AUTOMATIC PATHWAY WAS GENERATED. THE PHYSICIAN CHOSE TO DEVIATE FROM THE AUTOMATIC PATHWAY AND NAVIGATE MANUALLY. DUE TO A SPECIFIC SEQUENCE OF EVENTS, NO DIRECTIONAL NAVIGATION GUIDANCE WAS PROVIDED DUE TO A RARE AND ISOLATED SOFTWARE ANOMALY. NO SIMILAR CASES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN WAS UNABLE TO NAVIGATE TO THE TARGET LESION. THE PHYSICIAN CHOSE TO NAVIGATE MANUALLY TO THE TARGET BUT DISCOVERED ON FLUOROSCOPY, HE WAS NOT NEAR THE TARGET LESION. THE SUPERDIMENSION PORTION OF THE CASE WAS ABORTED AND THE CASE WAS COMPLETED USING OTHER METHODS. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION INREACH BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1