BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 192393 · Received October 19, 1998

    Report

    Report Number
    MW1014773
    Event Type
    Malfunction
    Date Received
    October 19, 1998
    Date of Event
    August 15, 1998
    Report Date
    September 30, 1998
    Manufacturer
    OLYMPUS AMERICAL INC. ENDOSCOPE DIVISION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENDOSCOPES FOUND TO HAVE WATER INSIDE SOAKING CAP, CAUSING WATER LEAKAGE INTO ELECTRONICS AND DAMAGING SCOPES. SOAKING CAPS FOUND TO HAVE LEAK TEST ACCESS PINS UNALIGNED WHICH MAY HAVE ALLOWED WATER TO LEAK INTO ELECTRONIC PORTION OF ENDOSCOPE. IT IS UNKNOWN WHETHER LEAK TESTING DEVICE CONTRIBUTED TO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ENDOSCOPE KOG OLYMPUS AMERICAL INC. ENDOSCOPE DIVISION PCF140L, CF100TL, G1F2TL00 *
    2 OLYMPUS ENDOSCOPE FDF OLYMPUS AMERICA INC. ENDOSCOPE DIVISION PCF140L, CF100TL, G1F2TL00 *
    3 OLYMPUS ENDOSCOPE FDF OLYMPUS AMERICA INC ENDOSCOPE DIVISION PCF140L, CF100TL, G1F2TL00 *
    4 OLYMPUS ENDOSCOPE FDF OLYMPUS AMERICA INC ENDOSCOPE DIVISION PCF140L, CF100TL, G1F2TL00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other