BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1616616 · Received February 9, 2010

    Report

    Report Number
    3004659744-2010-00004
    Event Type
    Injury
    Date Received
    February 9, 2010
    Date of Event
    January 11, 2010
    Report Date
    February 9, 2010
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    THE SITE REPORTED (ON (B) (6) 2010) THAT THEY HAD A SUPERDIMENSION CASE IN WHICH THE PT DEVELOPED A PNEUMOTHORAX. IT WAS REPORTED THAT A CHESTTUBE WAS PLACED AND THE PT WAS RELEASED FROM THE HOSP TEN DAYS LATER WITH NO FURTHER ISSUES. IT WAS REPORTED THAT THIS PT HAS BAD EMPHYSEMA. THERE WAS NO ALLEGATION THAT THE SUPERDIMENSION SYSTEM CAUSED THE REPORTED PNEUMOTHORAX.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization