BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1335384 · Received February 21, 2009

    Report

    Report Number
    3004962788-2009-00008
    Event Type
    Injury
    Date Received
    February 21, 2009
    Date of Event
    January 21, 2009
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT HE HAD A GOOD REGISTRATION OF 2.7. HOWEVER, IN THE LARGE AIRWAYS (TRACHEA AND MAINSTEM), THE LOCATABLE GUIDE APPEARED TO BE OUTSIDE THE AIRWAYS IN THE MEDIASTINUM. THE PHYSICIAN REPORTED THAT IT DID THE SAME THING WHEN HE RE-REGISTERED. IN 2009, IT WAS FURTHER REPORTED THAT A PNEUMOTHORAX WAS RECOGNIZED ON A ROUTINE POST-PROCEDURE FILM (THE PT PNEUMOTHORAX WAS ASYMPTOMATIC). IT WAS REPORTED THAT THE PT WAS OBSERVED OVERNIGHT AND CONTINUED BEING ASYMPTOMATIC AND THE PNEUMOTHORAX WAS GETTING SMALLER. THERE WAS NO INVASIVE INTERVENTION.

    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