BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 5003073 · Received August 14, 2015

    Report

    Report Number
    3004962788-2015-00058
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 21, 2015
    Report Date
    September 17, 2015
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUPERDIMENSION HAS REQUESTED THE DEVICE FOR EVALUATION BUT HAS NOT RECEIVED ANYTHING TO DATE. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE. PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT: 09/17/2015. A COMPONENT OF THE SUPERDIMENSION SYSTEM, CASE RECORDINGS, WERE RETURNED AND EVALUATED. THE EVALUATION RESULTED IN NO PROBLEM FOUND WITH THE SYSTEM. THE RECORDINGS CONFIRMED THE PHYSICIAN NAVIGATED BEYOND THE TARGET AND BREACHED THE PLEURA. THE PHYSICIAN STATED THAT HE EXPERIENCED NO DIFFICULTY WITH THE SUPERD NAVIGATION SYSTEM.

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A PNEUMOTHORAX DURING A SUPERDIMENSION PROCEDURE AND RECEIVED A CHEST TUBE. 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
    538314 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (COMMON NAME) JAK SUPERDIMENSION INC. AAS00161-20

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other| R