BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 5083482 · Received September 17, 2015

    Report

    Report Number
    3004962788-2015-00075
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 19, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE CALL WAS PERFORMED AT THE SITE AND THE EVALUATION SHOWED A CORRUPT MAPPING FILE. IT IS UNKNOWN HOW THE MAPPING FILE BECAME CORRUPT. A NEW MAPPING FILE WAS CREATED AND THE SYSTEM WAS RETURNED TO SERVICE. 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 IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED DIFFICULTY OBTAINING AN ADEQUATE REGISTRATION OF THE LUNGS DURING A SUPERDIMENSION CASE. THE CASE WAS CANCELLED AND 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
    615063 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1