BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 6283543 · Received January 27, 2017

    Report

    Report Number
    3004962788-2017-00018
    Event Type
    Death
    Date Received
    January 27, 2017
    Date of Event
    January 6, 2017
    Report Date
    January 6, 2017
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    A PATIENT HAD A SUPERDIMENSION ENB PROCEDURE ON (B)(6) 2016. THE SITE FOUND DURING CHART REVIEW THAT THE PATIENT HAD DIED ON (B)(6) 2017. NO CAUSE OF DEATH WAS INDICATED. THE SITE REPORTED THE PATIENT'S DEATH WAS NOT RELATED TO THE SUPERDIMENSION DEVICE OR THE ENB PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66180 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death