The subject device and concomitantly-used video processor and camera head were returned to the olympus for evaluation.Olympus checked the subject device with the other returned devices connected and confirmed all devices worked properly.Olympus could not determine which devices were contributed to the reported phenomenon because the phenomenon was not reproduced.The related devices were not found any abnormalities, so there was a possibility that the phenomenon was attributed to the user handling of the devices.The instruction manual of clv-s40 already mentions the appropriate device handling when clv-s40 has abnormalities.Olympus also checked the device history record of the subject device and there was no irregularity found.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.Please cross reference the associated complaint files: mfr report #: 8010047-2015-00142 and 8010047-2016-00043.
|