BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFRATOME HANDPIECE

    MDR report key: 16365 · Received September 23, 1994

    Report

    Report Number
    MW1003493
    Event Type
    Malfunction
    Date Received
    September 23, 1994
    Date of Event
    August 29, 1994
    Report Date
    September 7, 1994
    Manufacturer
    COHERENT MEDICAL DIV. COHERENT, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A NEW YAG LASER FILTER WAS ATTACHED TO THE LASER. WHEN THE LASER WAS ACTIVATED THERE WAS A "POP" AND A FLAME SHOT OUT FROM THE ACTIVE END OF THE FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFRATOME HANDPIECE INFRATOME HANDPIECE GEX COHERENT MEDICAL DIV. COHERENT, INC. 0614-459-03 041593

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR