BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 381385 · Received February 25, 2002

    Report

    Report Number
    8010047-2002-00009
    Event Type
    Malfunction
    Date Received
    February 25, 2002
    Date of Event
    January 22, 2002
    Report Date
    January 23, 2002
    Manufacturer
    THE OLYMPUS OPTICAL CO. LTD.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOSP REP REPORTED THAT LOSS OF IMAGE WAS EXPERIENCED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY (E.R.C.P.) PROCEDURE. THE DIAGNOSTIC EXAMINATION WAS COMPLETED WITH A SECOND SCOPE AND THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE IMAGE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS DUODENOSCOPE FDT THE OLYMPUS OPTICAL CO. LTD. JF-100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN