BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER, SURGICAL, ARGON

    MDR report key: 20670 · Received March 7, 1995

    Report

    Report Number
    20670
    Event Type
    Injury
    Date Received
    March 7, 1995
    Date of Event
    February 1, 1994
    Report Date
    February 7, 1995
    Manufacturer
    HGM, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A VITRECTOMY PROCEDURE THE LASER WAS SET AT 0.5 WATTS IN THE CONTINUOUS MODE AS PER MD ORDERS. WHILE THE LASER WAS IN USE,THE 0.5 WATT CHANGED SPONTANEOUSLY TO 0.9 WATTS RESULTING IN A RETINAL HEMORRHAGE PER MD. LASER WAS REMOVED FROM SERVICE UNTIL IT COULD BE TESTED BY MFR'S REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER, SURGICAL, ARGON ARGON LASER GEX HGM, INC. 5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other| R