BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFRATOME HANDPIECE

    MDR report key: 33313 · Received May 16, 1996

    Report

    Report Number
    33313
    Event Type
    Malfunction
    Date Received
    May 16, 1996
    Date of Event
    May 13, 1996
    Report Date
    May 14, 1996
    Manufacturer
    COHERENT MEDICAL, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIBER TIP DEFECTIVE: LIGHT HEATED METAL TUBE APPROX .5 TO 1 CM FROM TIP (THIS WAS BEING USED DURING AN ARTHROSCOPY). AS A RESULT, THE PT'S CONDITION SURFACE WAS BURNED SUPERFICIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFRATOME HANDPIECE LASER GEX COHERENT MEDICAL, INC. 30 DEGREE PROBE 103195

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other