BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1210971 · Received October 23, 2008

    Report

    Report Number
    MW5008757
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 23, 2008
    Manufacturer
    OLYMPUS
    Product Code
    FBN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING MANUAL CLEANING OF AN OLYMPUS TJF-160VF ENDOSCOPE, A PANCREATIC STENT WITH ATTACHED HEMO-CLIP WAS DISLODGED FROM THE SUCTION CHANNEL. THIS FOREIGN OBJECT WAS APPARENTLY LODGED IN THIS SCOPE DURING THE PAST FOUR PROCEDURES (STUCK IN SCOPE 2008 AND DISLODGED SIX DAYS LATER). THIS CHANNEL WAS MANUALLY BRUSHED AFTER EACH PT USE (AT LEAST FOUR TIMES) ACCORDING TO MANUFACTURER'S GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ERCP SCOPE FBN OLYMPUS TJF-160VF

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR