BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 3810031 · Received May 1, 2014

    Report

    Report Number
    3004962788-2014-00029
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    May 1, 2014
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUPERDIMENSION HAS REQUESTED DEVICES FROM THE SITE BUT HAS NOT RECEIVED ANYTHING FOR EVALUATION TO DATE. PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY.

    Description of Event or Problem · 1

    SITE REPORTED A PNEUMOTHORAX POST SUPERDIMENSION PROCEDURE. PATIENT RECEIVED OXYGEN VIA CHEST TUBE AND WAS HOSPITALIZED 2 NIGHTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262112 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization