BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 1020583 · Received March 28, 2008

    Report

    Report Number
    8010047-2008-00056
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 29, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY HAS ELECTED NOT TO RETURN THIS DEVICE TO OLYMPUS FOR INVESTIGATION. THE USER FACILITY HAS INDICATED THAT THE REPORTED EVENT WAS ATTRIBUTED TO THE NON-OLYMPUS AUTOMATIC ENDOSCOPE REPROCESSOR (AER) THAT WAS USED TO REPROCESS THIS DEVICE. THE AER HAS REPORTEDLY BEEN REMOVED FROM SERVICE. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST WAS DISPATCHED TO VISIT THE USER FACILITY AND CONDUCTED AN IN-SERVICE TRAINING ON HOW TO CLEAN AND HANDLE THE DEVICE. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED, THAT A PT WAS DIAGNOSED WITH CHEMICAL COLITIS AFTER UNDERGOING A DIAGNOSTIC COLONOSCOPY AT THEIR FACILITY. THE PT REPORTEDLY, EXPERIENCED DIARRHEA AND WAS ADMITTED TO THE HOSPITAL WITHIN 24 HOURS FOLLOWING THE PROCEDURE. THE PT WAS TREATED WITH ANTIBIOTICS AND WAS HOSPITALIZED FRO AN UNK AMOUNT OF TIME, BUT WAS SAID TO BE DOING FINE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II PEDIATRIC COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORPORATION PCF-Q180AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization