BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS COLONOVIDEOSCOPE

    MDR report key: 3773166 · Received February 11, 2014

    Report

    Report Number
    2951238-2014-00054
    Event Type
    Other
    Date Received
    February 11, 2014
    Report Date
    January 17, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES HAVE BEEN RETURNED TO OLYMPUS FOR EVALUATION. AS PART OF OUR INVESTIGATION WITH THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) VISITED THE USER FACILITY TO OBSERVE THE USER FACILITY'S REPROCESSING PRACTICES AND PROVIDED REPROCESSING TRAINING PER THE USER FACILITY'S REQUEST. DURING THE ONSITE VISIT ON FEBRUARY 7, 2014, THE ESS OBSERVED THAT THE STAFF WAS NOT USING THE SUCTION CLEANING ADAPTER. A SECOND IN-SERVICE HAS BEEN SCHEDULED FOR FEBRUARY 12, 2014, TO REVIEW PRE-CLEANING WITH THE NURSING STAFF. THIS REPORT WILL BE SUPPLEMENTED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT MORE THAN 100 PATIENTS WHO HAD UNDERGONE COLONOSCOPIES BETWEEN 2011 AND 2013 HAVE BEEN ADVISED TO BE TESTED FOR HEPATITIS B AND C, AND HIV DUE TO REPROCESSING CONCERNS AT THE USER FACILITY. THE USER FACILITY WAS NOT PRE-CLEANING, AND NOT REPROCESSING THE AUXILIARY WATER CHANNEL IN ACCORDANCE WITH THE DIRECTIONS FOR USE. NO PATIENT INFECTION OR CROSS-CONTAMINATION HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91088 OLYMPUS COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEM CORPORATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1