BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSITE XENON LIGHT SOURCE

    MDR report key: 1002065 · Received February 19, 2008

    Report

    Report Number
    1223925-2008-00001
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 19, 2008
    Manufacturer
    VISION SYSTEMS, INC.
    Product Code
    GCT
    PMA / PMN Number
    K864385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON 01/27/07, VIKING SALES REP PHONED IN COMPLAINT THAT AN ENDOSCOPE WAS HOT TO THE TOUCH. HE REPORTED THAT A 5MM R. WOLF SCOPE WAS INVOLVED. NO PT INJURY WAS REPORTED. LIGHT SOURCE USED TO BE SENT BACK FOR EVALUATION. IN 2008, CUSTOMER REPORTED THAT PT TISSUE WAS BURNT ONTO SCOPE. VIKING WAITING TO RECEIVE LIGHT SOURCE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSITE XENON LIGHT SOURCE LIGHT SOURCE GCT VISION SYSTEMS, INC. 8050-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1