BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS OES CHOLEDOCHOFIBERSCOPE

    MDR report key: 1553123 · Received December 2, 2009

    Report

    Report Number
    8010047-2009-00254
    Event Type
    Other
    Date Received
    December 2, 2009
    Report Date
    November 6, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FBN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RETURNED TO OLYMPUS FOR EVALUATION IN ASSOCIATION WITH THIS REPORT. THERE WAS NO ALLEGATION OF ANY DEFICIENCIES IN THE PRODUCT WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THIS REPORT. BASED UPON THE INFO PROVIDED, THE USERS WERE NOT REPROCESSING THE DEVICES IN ACCORDANCE WITH THE DEVICE INSTRUCTION MANUAL. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST HAS PROVIDED IN-SERVICE TRAINING TO THE USER FACILITY STAFF ON APPROPRIATE REPROCESSING OF ENDOSCOPES. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT USERS AT THE FACILITY WERE NOT BRUSHING THE INSTRUMENT CHANNEL AND SUCTION CONNECTOR DURING MANUAL CLEANING OF THE ENDOSCOPES. THE ENDOSCOPES WERE REPORTED TO HAVE UNDERGONE ETHYLENE OXIDE STERILIZATION FOLLOWING REPROCESSING. THERE WERE NO REPORTS OF PT CROSS-CONTAMINATION OR INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS OES CHOLEDOCHOFIBERSCOPE CHOLEDOCHOSCOPE FBN OLYMPUS MEDICAL SYSTEMS CORPORATION CHF-P20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1