BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 328644 · Received April 20, 2001

    Report

    Report Number
    8010047-2001-00029
    Event Type
    Malfunction
    Date Received
    April 20, 2001
    Date of Event
    February 27, 2001
    Report Date
    March 1, 2001
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOSP NURSE MANAGER REPORTED LOSS OF IMAGE DURING A DIAGNOSITC COLONOSCOPY PROCEDURE. THERE WERE NO INJURIES RELATED TO THE OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18038 OLYMPUS COLONOSCOPE FDF OLYMPUS OPTICAL CO. LTD. CF-100L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN