BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 5079148 · Received September 15, 2015

    Report

    Report Number
    3004962788-2015-00072
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    August 17, 2015
    Report Date
    November 4, 2015
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT: 11/05/2015. A COMPONENT OF THE SUPERDIMENSION SYSTEM WAS RETURNED AND EVALUATED WHICH SHOWED THE ISSUE WAS NOT SOFTWARE RELATED. AN ON-SITE SERVICE VISIT WAS PERFORMED AND THE ISSUE COULD NOT BE NOT DUPLICATED, HOWEVER THE IPC WAS REPLACED AS A PRECAUTION. THE IPC WAS RETURNED AND EVALUATED AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPONENT OF THE SUPERDIMENSION SYSTEM, THE WINDOWS LOGS, HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED. OUT OF AN ABUNDANCE OF CAUTION, SUPERDIMENSION IS FILING THIS MDR DUE TO THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SITE REPORTED THE SUPERDIMENSION ILOGIC SYSTEM TURNED OFF DURING THE PROCEDURE AND THE PHYSICIAN CANCELED THE SUPERDIMENSION PORTION OF THE CASE. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO REPORT OF PATIENT INJURY, DEATH OR OTHER SERIOUS ADVERSE EVENT. 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
    607951 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20

    Patients

    Seq Age Sex Outcome Treatment
    1