BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS DSD-91 AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 383193 · Received March 13, 2002

    Report

    Report Number
    MW1024435
    Event Type
    Other
    Date Received
    March 13, 2002
    Date of Event
    March 7, 2002
    Report Date
    March 13, 2002
    Manufacturer
    MEDIVATORS, INC.
    Product Code
    FEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AN ENDOSOCPY CENTER NURSE MGR REPORTED THAT TWO PTS UNDERWENT COLONOSCOPY PROCEDURES WITH COLONOSCOPES THAT DID NOT GO THROUGH THE REQUIRED DISINFECTION CYCLE DURING REPROCESSING IN AN OLYMPUS DSD AUTOMATED ENDOSCOPE DISINFECTOR. THE NURSE ATTRIBUTED THE EVENT TO HUMAN ERROR AND NOT A MALFUNCTION OF THE AUTOMATED REPROCESSOR. THERE WERE NO REPORTS OF CONTAMINATION OR INFECTIONS ASSOCIATED WITH THE ERROR. THE PHYSICIAN CONTACTED BOTH PTS ABOUT THE REPROCESSING ERROR; THEY WILL UNDERGO BLOOD TESTS FOR INFECTIOUS DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS DSD-91 AUTOMATIC ENDOSCOPE REPROCESSOR AUTOMATIC ENDOSCOPE REPROCESSOR FEB MEDIVATORS, INC. DSD-91E NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other