BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 6034316 · Received October 17, 2016

    Report

    Report Number
    3004962788-2016-00271
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPONENT OF THE SYSTEM, CASE RECORDINGS HAVE BEEN REQUESTED FOR EVALUATION BUT HAVE NOT YET BEEN RECEIVED. 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 ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA.

    Description of Event or Problem · 1

    SITE REPORTED THE SUPERDIMENSION SYSTEM HAD ACCURACY ISSUES DURING AN ENB PROCEDURE AND THE PHYSICIAN CANCELLED THE CASE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO REPORT OF PATIENT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685278 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1