BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 802071 · Received June 14, 2006

    Report

    Report Number
    MW1041531
    Event Type
    Other
    Date Received
    June 14, 2006
    Date of Event
    May 26, 2006
    Report Date
    June 14, 2006
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN CLEANING ERCP SCOPE AFTER PROCEDURE, TECH NOTICED PIECE OF PLASTIC AT TIP OF SCOPE WAS BROKEN OFF. RN WHO SET UP CASE PRIOR TO PROCEDURE STATED TIP WAS INTACT AT BEGINNING OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ERCP SCOPE FTK OLYMPUS AMERICA, INC. TSF 130 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other