BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLT SURGICAL LASER TECHNOLOGIES

    MDR report key: 241792 · Received September 24, 1999

    Report

    Report Number
    2523356-1999-00002
    Event Type
    Injury
    Date Received
    September 24, 1999
    Date of Event
    July 23, 1999
    Report Date
    September 3, 1999
    Manufacturer
    SURGICAL LASER TECHNOLOGIES, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    LASER ASSISTED REMOVAL OF TUMOR FROM RIGHT MAIN STEM OF BRONCHUS. INTERMITTENT USE OF 100% OXYGEN VIA FACE MASK. SUBSEQUENT PLACEMENT OF ENDOTRACHEAL TUBE WITH PORTEX ADAPTOR. DURING PROCEDURE "SMALL EXPLOSION" OCCURRED INSIDE THE BRONCHUS. PT SUFFERED SERIOUS BURN AND IS UNDER PHYSICIAN CARE. BRONCHOSCOPE AND ENDOTRACHEAL TUBE WERE BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLT SURGICAL LASER TECHNOLOGIES CONTACT LASER & FIBER DELIVERY SYSTEM GEX SURGICAL LASER TECHNOLOGIES, INC. CL 100 LASER; SFE 0.6 FIBER SFE 0.6 - 709504

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L| R| S