BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS A3295 LIGHT CABLE

    MDR report key: 623682 · Received July 6, 2005

    Report

    Report Number
    623682
    Event Type
    Other
    Date Received
    July 6, 2005
    Date of Event
    June 17, 2005
    Report Date
    July 1, 2005
    Manufacturer
    OLYMPUS AMERICA, INC
    Product Code
    KOG
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POST ENDOMETRIAL ABLATION,PATIENT WAS DISCHARGED HOME AND AWOKE WITH "DIME SIZED BURN TO LEFT GROIN AREA" EQUIPMENT USED DURING PROCEDURE WAS A HYSTEROSCOPE, FIBER OPTIC LIGHT CABLE AND FIBER OPTIC LIGHT SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS A3295 LIGHT CABLE FIBER OPTIC LIGHT CABLE KOG OLYMPUS AMERICA, INC * *
    2 * HYSTEROSCOPE KOG OLYMPUS AMERICA, INC A4674A *
    3 OLYMPUS OTV-56 FIBEROPTIC LIGHT SOURCE LIGHT SOURCE KOG OLYMPUS AMERICA, INC A3295 *

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR