BEUDAMED
    FDA Adverse Event Other Summary report: N

    XL40+

    MDR report key: 96950 · Received June 5, 1997

    Report

    Report Number
    2914019-1997-00019
    Event Type
    Other
    Date Received
    June 5, 1997
    Date of Event
    April 30, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS AN INCIDENT IN WHICH THERE WAS A FIRE. THE DR WAS DOING A MICROLARYNGOSCOPY. THE ET TUBE (NOT MFG BY COHERENT) SPARKED, CAUSING A FLAME. THE DR THEN THREW THE TUBE ON THE FLOOR AND STOMPED THE FLAME OUT. THE PT RECEIVED A WHITE POWDERY RESIDUE IN THE THROAT. THE LASER RENTAL COMPANY HAD VERIFIED THE LASER WAS WORKING PROPERLY AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XL40+ CO2 LASERS GEX COHERENT MEDICAL LASER GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention