BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2467115 · Received February 15, 2012

    Report

    Report Number
    3004962788-2012-00004
    Event Type
    Injury
    Date Received
    February 15, 2012
    Date of Event
    January 9, 2012
    Report Date
    February 15, 2012
    Manufacturer
    SUPERDIMENSION, INC.
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PNEUMOTHORAX IS A KNOWN COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY, OR CT- GUIDED PERCUTANEOUS BIOPSY WITH COMPLICATION RATES UP TO APPROXIMATELY 27% WITH THE CT- GUIDED PROCEDURE. BIOPSY TOOLS ARE DESIGNED TO HAVE SHARP EDGES AND THEIR FUNCTION IS TO PUNCTURE OR OTHERWISE PENETRATE THE TISSUE IN ORDER TO COLLECT A SPECIMEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PT RECEIVED FIDUCIAL MARKERS. WITHIN 2 DAYS OF THE PROCEDURE, PT RETURNED TO ANOTHER HOSPITAL WITH PAINS. PT HAD PNEUMOTHORAX AS CONFIRMED ON CT. THE PNEUMOTHORAX OCCURRED WHERE TUBING AND MAKERS WERE PRESENT. PT WAS HOSPITALIZED FOR ONE DAY AND THEN WAS RELEASED. PT IS DOING FINE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization