The device referenced in this report was not returned to olympus for evaluation.The exact cause of the patient's outcome could not be conclusively determined at this time.As part of our investigation, olympus dispatched an endoscopy support specialist (ess) to the user facility to observe their reprocessing practices.At this time the user facility has not yet scheduled a date for the in-service.If additional and significant information becomes available at a later time, this report will be supplemented.
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