BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 419107 · Received September 26, 2002

    Report

    Report Number
    MW1026282
    Event Type
    Injury
    Date Received
    September 26, 2002
    Date of Event
    September 16, 2002
    Report Date
    September 17, 2002
    Manufacturer
    OLYMPUS AMERICA INC
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    OLYMPUS ENDOSCOPE 140 L, BIOPSY PORT COVER MPN # MD 358. DEVICE WEAR CAUSING MATERIAL SEPARATION. SEPARATED MATERIAL FROM PORT COVER CLOGGING BIOPSY CHANNEL AND POSSIBLE PT EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS BIOPSY PORT CAP #MD 358 KOG OLYMPUS AMERICA INC MD358 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R