BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 357624 · Received October 18, 2001

    Report

    Report Number
    8010047-2001-00078
    Event Type
    Malfunction
    Date Received
    October 18, 2001
    Report Date
    September 17, 2001
    Manufacturer
    THE OLYMPUS OPTICAL CO.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOSP INFECTION CONTROL NURSE REPORTED THAT 16 OUT OF 34 BRONCHIAL WASHINGS OR BRUSHINGS CULTURED POSITIVE FOR PSEUDOMONAS AERUGINOSA AND AT LEAST SIX OF THE PT SAMPLES WERE ALSO CONTAMINATED WITH SERRATIA MARCESCENS. THE BRONCHIAL WASHINGS WERE TAKEN FROM THE PT'S WHO WERE NOT ILL AND HAD NO HISTORY OR PSEUDOMONAS PRIOR TO THE PROCEDURE. THREE DAYS AFTER UNDERGOING A BRONCHOSCOPY EXAM WITH A SUSPECT SCOPE, ONE PT WAS ADMITTED TO THE HOSP WITH PSEUDOMANAS PNEUMONIA. THE NURSE DOES NOT KNOW IF THE PT WAS INCUBATING THE PSEUDOMONAS PNEUMONIA BEFORE THE BRONCHOSCOPY PROCEDURE. A SECOND PT WAS ADMITTED TO THE FACILITY WITH PRE-EXISTING PENUMONIA AND OTHER HEALTH PROBLEMS (NOT SPECIFIED). THE NEXT DAY, THE PT WAS EXAMINED WITH AN OLYMPUS BRONCHOSCOPE. BRONCHIAL WASHINGS CULTURED POSITIVE FOR PSEUDOMONAS AND TREATMENT WAS PRESCRIBED. ACCORDING TO THE NURSE, 14 OF 16 PT'S DID NOT CONTRACT PSEUDOMONAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46947 OLYMPUS VIDEO BRONCHOSCOPE EOQ THE OLYMPUS OPTICAL CO. BF-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN