BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 5080964 · Received September 16, 2015

    Report

    Report Number
    3004962788-2015-00073
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    June 24, 2015
    Report Date
    September 16, 2015
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE CALL WAS PERFORMED AT THE SITE AND THE EVALUATION COULD NOT IDENTIFY ANY ANOMALIES. DISCUSSION WITH THE SITE DETERMINED THAT THE PATIENT WAS NOT PLACED PROPERLY ON THE BED AND LOCATION BOARD AS REQUIRED FOR THE ENB PROCEDURE AND THAT EXTERNAL EQUIPMENT WAS CLOSER TO THE SYSTEM THAN ALLOWED PER USER MANUAL. THE ACCOUNT MANAGER PROVIDED REFRESHER TRAINING ON PROCEDURE SET-UP FOR THE SUPERDIMENSION SYSTEM. OUT OF AN ABUNDANCE OF CAUTION, SUPERDIMENSION IS FILING THIS MDR DUE TO THE ADDITIONAL RISK ASSOCIATED WITH MULTIPLE EXPOSURES TO GENERAL ANESTHESIA. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SITE REPORTED THEY EXPERIENCED DIFFICULTIES IN ACHIEVING AN ADEQUATE REGISTRATION OF THE PATIENT'S LUNGS DURING THE SUPERDIMENSION PROCEDURE. THE PHYSICIAN CANCELLED THE PROCEDURE. 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
    611101 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20

    Patients

    Seq Age Sex Outcome Treatment
    1