The device was not returned to olympus medical systems corp.(omsc), but returned to olympus repair center for evaluation.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Omsc surmised that this phenomenon attributed to the following.Physical stress caused by hitting the distal end against an object.Chemical stress caused by the chemical agent used at the reprocessing.Storage environment at the user facility.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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