BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE

    MDR report key: 35237 · Received July 17, 1996

    Report

    Report Number
    35237
    Event Type
    Malfunction
    Date Received
    July 17, 1996
    Date of Event
    May 13, 1996
    Report Date
    May 14, 1996
    Manufacturer
    COHERENT MEDICAL DIVISION
    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 PROBE PROBE GEX COHERENT MEDICAL DIVISION 30 DEGREE PROBE 103195

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other