BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 833283 · Received March 19, 2007

    Report

    Report Number
    8010047-2007-00034
    Event Type
    Malfunction
    Date Received
    March 19, 2007
    Report Date
    February 22, 2007
    Manufacturer
    OLYMPUS OPTICAL CO. LTD.
    Product Code
    GCK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS SENT TO AN OFF-SITE MICROBIOLOGY LABORATORY FOR MICROBIOLOGIC SAMPLING PRIOR TO OLYMPUS PERFORMING A QUALITY INSPECTION. OLYMPUS CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE AT THIS TIME. HOWEVER, THE PHYSICAL CONDITION OF THE SCOPE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THIS REPORT WILL BE SUPPLEMENTED WITH THE LABORATORY RESULT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY HAVE CULTURED ALL THEIR ENDOSCOPES THAT WERE REPROCESSED IN CUSTOM ULTRASONIC SYSTEM 83 IN RESPONSE TO THE RECENT FDA WARNING REGARDING REPROCESSING OF FLEXIBLE ENDOSCOPES WITH THIS MACHINE. THE FACILITY REPORTED THAT THEY HAVE TOTAL OF EIGHT FLEXIBLE ENDOSCOPES. SIX FLEXIBLE ENDOSCOPES WERE TESTED NEGATIVE FOR MICROORGANISM, BUT TWO ENDOSCOPES WERE POSITIVE. THE TWO POSITIVE ENDOSCOPES WERE REPROCESSED THROUGH CUSTOM ULTRASONIC SYSTEM 83 AND THEN THROUGH STERIS SYSTEM 1. BOTH ENDOSCOPES WERE CULTURED AGAIN; ONE OF THE TWO ENDOSCOPES WAS TESTED NEGATIVE. ACCORDING TO THE FACILITY, THERE WAS NO PT COMPLAINTS AND NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS GASTROSCOPE GCK OLYMPUS OPTICAL CO. LTD. GIF-160 *

    Patients

    Seq Age Sex Outcome Treatment
    1 YR