BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS

    MDR report key: 386951 · Received April 8, 2002

    Report

    Report Number
    2429304-2002-00001
    Event Type
    Other
    Date Received
    April 8, 2002
    Report Date
    March 7, 2002
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN ENDOSCOPY CENTER NURSE MANAGER REPORTED THAT TWO PATIENTS UNDERWENT COLONOSCOPY PROCEDURES WITH COLONOSCOPES THAT HAD NOT BEEN IN CONTACT WITH CIDEX OPA DURING REPROCESSING IN AN OLYMPUS DSD 91E AUTOMATED ENDOSCOPE DISINFECTOR (AER). THE NURSE ATTRIBUTED THE EVENT TO HUMAN ERROR AND NOT A MALFUNCTION OF THE AER. THE PHYSICIAN CONTACTED BOTH PATIENTS ABOUT THE REPROCESSING ERROR; THE PATIENTS WILL UNDERGO BLOOD TESTS FOR INFECTIOUS DISEASE. THE NURSE STATED THAT THERE WERE NO IMMEDIATE REPORTS OF CONTAMINATION OR INFECTIONS ASSOCIATED WITH THE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS AUTOMATIC DISINFECTOR FEB OLYMPUS AMERICA, INC. DSD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other