BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PC-EDO

    MDR report key: 581377 · Received March 8, 2005

    Report

    Report Number
    581377
    Event Type
    Malfunction
    Date Received
    March 8, 2005
    Date of Event
    February 28, 2005
    Report Date
    March 3, 2005
    Manufacturer
    HGM
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING THE LASER DURING A PROCEDURE. PHYSICIAN WENT TO ACTIVATE THE LASER WITH THE FOOTPEDAL, AND THERE WAS A FLASH OF THE LASER, THE LASER FAULTED, AND THE LASER SHUT OFF. THE PT'S EYES WERE PAINFUL, AND WAS SEEN BY A PRIVATE PHYSICIAN (OPHTHALMOLOGIST). THE CASE WAS COMPLETED WITH ANOTHER FOOTPEDAL FOR THE LASER WITH NO ADDITIONAL OCCURRENCES. THE FOOTPEDALS, EYEPIECES, AND LASER WERE TAKEN OUT OF SERVICE UNTIL A COMPLETE INSPECTION COULD BE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PC-EDO LASER GEX HGM E02-A-A01-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other