This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc), therefore omsc cannot investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, omsc surmised that this phenomenon is attributed to the inappropriate handling by the user.If additional information becomes available, this report will be supplemented.
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