BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    70/100 HO LASER ND

    MDR report key: 118660 · Received September 9, 1997

    Report

    Report Number
    MW1012049
    Event Type
    Malfunction
    Date Received
    September 9, 1997
    Date of Event
    July 7, 1997
    Report Date
    September 8, 1997
    Manufacturer
    COHERENT MEDICAL LASERS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO HOURS INTO SURGERY, ANESTHESIOLOGIST REQUESTED AN ELECTRICAL FAN TO KEEP RENTAL LASER FROM OVERHEATING. EQUIPMENT SEQUESTERED AND RETURNED TO THE RENTAL COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 70/100 HO LASER ND LASER GEX COHERENT MEDICAL LASERS VP SELECT - LONG ROD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other