BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION

    MDR report key: 11919992 · Received June 2, 2021

    Report

    Report Number
    3004962788-2021-00050
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 2, 2021
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ENB-GUIDED MICROWAVE ABLATION COMBINED WITH UNIPORTAL VATS FOR MULTIPLE GROUND SOURCE: THE ANNALS OF THORACIC SURGERY (2021), ACCEPTED DATE: (B)(6) 2021 (B)(4) (SUBCUTANEOUS EMPHYSEMA) PNEUMOTHORAX IS A KNOWN SHORT-TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY, ELEVEN PATIENTS WITH MULTIPLE GROUND GLASS OPACITIES (GGOS) UNDERWENT ENB-GUIDED MICROWAVE ABLATION COMBINED WITH UNI-VATS. ONLY ONE PATIENT DEVELOPED POSTOPERATIVE PNEUMOTHORAX AND SUBCUTANEOUS EMPHYSEMA AND WAS SUCCESSFULLY DISCHARGED FROM THE HOSPITAL AFTER TREATMENT. ENB-GUIDED MICROWAVE ABLATION COMBINED WITH UNIPORTAL VATS FOR MULTIPLE GROUND GLASS OPACITIES. RIRONG QU; (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816630 SUPERDIMENSION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK AAS00161-20 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention