BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GHERINI-KAUFMANN ENDO OTO PROBE

    MDR report key: 16793 · Received October 13, 1994

    Report

    Report Number
    MW1003670
    Event Type
    Injury
    Date Received
    October 13, 1994
    Date of Event
    September 6, 1994
    Report Date
    September 27, 1994
    Manufacturer
    HGM MEDICAL LASER SYSTEMS, INC.
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE SURGEON STATED THE LASER WASN'T WORKING. LASER PROBE HAD BEEN TESTED AND WORKED PRIOR TO BEGINNING OF PROCEDURE. IN EXAMINATION IT WAS NOTED THE LASER PROBE WAS BROKEN IN HALF. THERE WAS NO EVIDENCE ON OBSERVATION OF THE DRAPE BEING BURNED OR MELTED. THE PROBE WAS CHANGED AND THE CASE PROCEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GHERINI-KAUFMANN ENDO OTO PROBE LASER ENERY DELIVERY PROBE HQF HGM MEDICAL LASER SYSTEMS, INC. FLP050-G01-U-S 00494F50A-01

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention