BEUDAMED
    FDA Adverse Event Death Summary report: N

    3004659744-2008-00015

    MDR report key: 1131223 · Received August 20, 2008

    Report

    Report Number
    3004659744-2008-00015
    Event Type
    Death
    Date Received
    August 20, 2008
    Product Code
    JAK
    PMA / PMN Number
    K042438
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    PNEUMOTHORAX IS A KNOWN COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY, OR CT-GUIDED PERCUTANEOUS BIOPSY WITH COMPLICATION RATES UP TO APPROX 27% WITH THE CT GUIDED PROCEDURE. BIOPSY TOOLS ARE DESIGNED TO HAVE SHARP EDGES AND THEIR FUNCTION IS TO PUNCTURE OR OTHERWISE, PENETRATE THE TISSUE IN ORDER TO COLLECT A SPECIMEN. ALTHOUGH REGISTRATION WAS REPORTED AS BEING DIFFICULT, THE PHYSICIAN WAS ABLE TO OBTAIN A CT-TO-BODY DIVERGENCE WITHIN SPECIFICATION (< 10 MM) FOR THIS CASE AND THE CASE IMMEDIATELY FOLLOWING. THE INREACH SYSTEM WAS DEMONSTRATED TO BE WORKING DURING AND AFTER THE REPORTED CASE, AS SHOWN THROUGH SUCCESSFUL REGISTRATION RESULTS, AND NO REPORTED SYS ERRORS. THE CASE FOLLOWING THIS REPORTED CASE HAD A DIVERGENCE RESULT OF 3.5MM (SPECIFICATION: < 10 MM) AND A SUCCESSFUL NAVIGATION TO TARGET AND BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAK * *

    Patients

    Seq Age Sex Outcome Treatment
    1