BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 384214 · Received March 18, 2002

    Report

    Report Number
    384214
    Event Type
    Injury
    Date Received
    March 18, 2002
    Report Date
    March 1, 2002
    Manufacturer
    OLYMPUS AMERICA, INC
    Product Code
    EOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, THE HOSPITAL EPIDEMIOLOGY AND INFECTION CONTROL DEPT RECEIVED A REPORT FROM A PULMONARY PHYSICIAN OF THREE UNEXPECTED CASES OF PSEUDOMONAS PNEUMONIA. TWO OF THESE PTS HAVE DIED. THE REPORT OF THE UNEXPECTED INFECTIONS PROMPTED A FORMAL EPIDEMIOLOGICAL INVESTIGATION. THE INVESTIGATION HAS REVEALED A HIGHER THAN EXPECTED RATE OF CULTURE ISOLATES OF PSEUDOMONAS IN PTS UNDERGOING BRONCHOALVEOLAR LAVAGE ("BAL") IN THE LAST HALF OF 2001. THE BRONCHOSCOPES USED WERE MANUFACTURED BY OLYMPUS AMERICA, INC, WHICH HAS ORDERED A NATIONAL RECALL OF THE INSTRUMENTS BASED ON A REPORT OF BRONCHOSCOPE CONTAMINATION AT ANOTHER INSTITUTION. THEIR PRELIMINARY INVESTIGATION ALSO HAS REVEALED ADD'L UNEXPECTED PSEUDOMONAS INFECTIONS WHICH THEY BELIEVE ARE RELATED TO THE DEFECTIVE BRONCHOSCOPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK BRONCHOSCOPE EOQ OLYMPUS AMERICA, INC BF-160 *
    2 UNK BRONCHOSCOPE EOQ OLYMPUS AMERICA, INC. BF-1T160 *
    3 UNK BRONCHOSCOPE EOQ OLYMPUS AMERICA, INC. BF-P40 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R