BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 4929569 · Received July 21, 2015

    Report

    Report Number
    3004962788-2015-00051
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    June 25, 2015
    Report Date
    July 21, 2015
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUPERDIMENSION HAS REQUESTED THE DEVICE FOR EVALUATION BUT HAS NOT RECEIVED ANYTHING TO DATE. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE. OUT OF AN ABUNDANCE OF CAUTION, SUPERDIMENSION IS FILING THIS MDR DUE TO THE PATIENT REPORTING THIS ONE DAY POST- ENB PROCEDURE THOUGH NO INTERVENTION WAS REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT DID NOT REQUIRE MEDICAL INTERVENTION AND DOES NOT MEET THE CRITERIA FOR A SERIOUS INJURY THEREFORE IS NOT A REPORTABLE EVENT.

    Description of Event or Problem · 1

    PATIENT CALLED HOSPITAL ONE DAY POST-PROCEDURE FOR ENB AND REPORTED A SMALL AMOUNT OF BLOOD IN HIS SPUTUM DURING TWO COUGHING EPISODES. HE STATED IT HAD SINCE RESOLVED. PER SITE NO INTERVENTION WAS REQUIRED. PHYSICIAN DID NOT FEEL THIS WAS DUE TO THE SUPERDIMENSION ENB DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471205 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1 Other