This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.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.Since the subject device was not returned to omsc, the exact cause was unknown.As 13 years or more has passed since the manufacture date of the subject device, omsc surmised that the reported phenomenon was occurred due to deterioration due to repeated use for a long time.
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