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.Since replacement repair of the maj-1430 was carried out, omsc surmised that there was no problem in the subject device and the reported phenomenon occurred due to a failure of the maj-1430.
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