BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-LOGIC INREACH SYSTEM

    MDR report key: 5198098 · Received November 3, 2015

    Report

    Report Number
    3004962788-2015-00109
    Event Type
    Injury
    Date Received
    November 3, 2015
    Date of Event
    October 8, 2015
    Report Date
    November 3, 2015
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K102604
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT : 11/3/2015. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED ANOTHER FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE DEVICE LOT NUMBER. 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.

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A PNEUMOTHORAX DURING A SUPERDIMENSION PROCEDURE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION OR INTERVENTION. THE PHYSICIAN STATED THAT HE SUCCESSFULLY REACHED THE TARGET LESION AND OBTAINED BIOPSIES INITIALLY BUT THEN WAS UNABLE TO PASS BIOPSY TOOLS THROUGH THE EWC. UPON REMOVAL OF THE EWC IT WAS FOUND THAT THE TELESCOPE HAD BECOME DISCONNECTED FROM THE EWC. THE PROCEDURE WAS ABORTED. 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
    728017 I-LOGIC INREACH SYSTEM EDGE EWC 180 WITH TELESCOPE JAK SUPERDIMENSION INC. 178-5 E103496

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O