BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFRATOME

    MDR report key: 102589 · Received March 13, 1997

    Report

    Report Number
    102589
    Event Type
    Malfunction
    Date Received
    March 13, 1997
    Date of Event
    January 3, 1997
    Report Date
    March 12, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIBER RUPTURED. WITH LASER IN "READY" MODE, MD DEPRESSED FOOT PEDAL FOR FIRST ACTIVATION. THE FIBER RUPTURED APPROXIMATELY 3 FEET FROM ITS DISTAL TIP. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFRATOME FIBER OPTIC LASER GEX COHERENT MEDICAL LASER GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN