BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ENDOSCOPES

    MDR report key: 1760585 · Received July 13, 2010

    Report

    Report Number
    8010047-2010-00133
    Event Type
    Other
    Date Received
    July 13, 2010
    Date of Event
    March 1, 2010
    Report Date
    June 16, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION. OLYMPUS WAS INFORMED THAT THE ISSUE HAD BEEN IDENTIFIED BY HOSPITAL INFECTION CONTROL PERSONNEL DURING ROUTINE SURVEILLANCE AND HAS BEEN CORRECTED. OLYMPUS WAS ALSO INFORMED THAT THE HIGH-LEVEL DISINFECTANT HAD BEEN TESTED FOR MINIMUM EFFECTIVE CONCENTRATION DAILY PRIOR TO USE, AND INDICATED THAT IT PASSED TESTING. OLYMPUS ENDOSCOPE SERVICE SPECIALIST (ESS) HAS PROVIDED TRAINING TO REPROCESSING PERSONNEL FOR THIS FACILITY. BASED UPON THE INFORMATION PROVIDED AS PART OF THE REPORT, IT APPEARS TO BE A CASE OF USER ERROR. 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 OVER THE PERIOD OF A MONTH, HOSPITAL PERSONNEL REPORTEDLY REPROCESSED FLEXIBLE ENDOSCOPE DEVICES IN HIGH-LEVEL DISINFECTANT SOLUTIONS THAT WERE SLIGHTLY OUTSIDE THE MANUFACTURER'S RECOMMENDATIONS. THERE WERE NO REPORTS OF ANY PATIENT CROSS CONTAMINATIONS ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ENDOSCOPES ENDOSCOPES KOG OLYMPUS MEDICAL SYSTEMS CORPORATION ENDOSCOPES NA

    Patients

    Seq Age Sex Outcome Treatment
    1