BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSTAT LASER

    MDR report key: 1010550 · Received February 4, 2008

    Report

    Report Number
    1010550
    Event Type
    Malfunction
    Date Received
    February 4, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 4, 2008
    Manufacturer
    LASERSCOPE
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS INTUBATED WITH A SIZE NINE ENDOTRACHAEL TUBE, AND A FLEXIBLE BRONCHOSCOPE WAS USED TO OBTAIN MULTIPLE BIOPSIES AND TWO FROZEN SECTIONS. ADDITIONAL BIOPSIES WERE DONE AND PLACED IN FORMALIN. NECROTIC AND PIECEMEAL DEBRIDEMENT ENSUED. THE PATIENT WAS EXTUBATED AND REINTUBATED WITH A RIGID BRONCHOSCOPE, AND BLUNT DISSECTION OF THE RIGHT MAINSTEM TUMOR ENSUED. THERE WERE MULTIPLE LARGE PIECES OF TISSUE THAT WERE REMOVED AND PLACED IN FORMALIN. THE PATIENT WAS EXTUBATED AND REINTUBATED WITH SIZE EIGHT ENDOTRACHAEL TUBE, AND THE FLEXIBLE BRONCHOSCOPE WAS USED TO SUCTION THE AIRWAY CLEAN. CYTOLOGY BRUSHINGS TIMES TWO WERE USED TO BRUSH THE TUMOR AS WELL. THE RIGHT UPPER LOBE WAS CLEARLY VISUALIZED. THE RIGHT UPPER LOBE HAD BEEN COLLAPSED FOR A FEW MONTHS. THE TIP OF THE LASER FIBER FELL OFF INTO THE MAINSTEM BRONCHUS BEFORE BLUNT DISSECTION OF THE TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT LASER LASER FIBER GEX LASERSCOPE L66D 16-8319-635

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR