BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 6303318 · Received February 6, 2017

    Report

    Report Number
    3004962788-2017-00023
    Event Type
    Death
    Date Received
    February 6, 2017
    Date of Event
    July 14, 2016
    Report Date
    January 18, 2018
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE APPROPRIATE DEVICE HISTORY RECORDS OF THE SUPERDIMENSION CONSOLE INDICATES THIS DEVICE WAS RELEASED MEETING ALL QUALITY SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THE PATIENT DIED FROM LUNG CANCER AND MALIGNANT PLEURAL EFFUSION WITH RESPIRATORY DISTRESS.

    Description of Event or Problem · 1

    A PATIENT HAD A SUPERDIMENSION ENB PROCEDURE ON (B)(6) 2016. THE PATIENT DIED FROM LUNG CANCER ON (B)(6) 2016. THE SITE REPORTED THE PATIENT'S DEATH WAS NOT RELATED TO THE SUPERDIMENSION DEVICE OR THE ENB PROCEDURE.

    Description of Event or Problem · 1

    THE SITE REPORTED THE CAUSE OF DEATH WAS METASTATIC BREAST CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86897 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20U 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death