BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 5052247 · Received September 2, 2015

    Report

    Report Number
    3004962788-2015-00064
    Event Type
    Injury
    Date Received
    September 2, 2015
    Date of Event
    July 28, 2015
    Report Date
    September 2, 2015
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE. PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A PNEUMOTHORAX DURING A SUPERDIMENSION PROCEDURE WHICH WAS CONFIRMED BY POST-OP CHEST X-RAY. THE PATIENT WAS ASYMPTOMATIC AND DID NOT REQUIRE INTERVENTION OR HOSPITALIZATION. A FOLLOW-UP OFFICE VISIT THE FOLLOWING DAY SHOWED IMPROVEMENT IN THE PNEUMOTHORAX AND IT WAS REPORTED THAT THE PATIENT REMAINED ASYMPTOMATIC. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581422 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1 Other