The subject device was not returned to omsc for evaluation but was returned to olympus europa se & co.Kg (oekg).Oekg checked the subject device and found that the reported phenomenon was duplicated, and also found that the front panel of the subject device was broken and the power of the subject device was not turned on.The exact cause has been under investigation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
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This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus europa se & co.Kg (oekg).Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomena (no image and power up failure) could not be conclusively determined.However, based upon the information from oekg, omsc surmised that the reported phenomena were attributed to the failures of the front panel and the internal components such as the printed circuit board or the power supply unit, which might be caused by the strong impact (dropping of the device, collision of hard objects, etc.).If additional information is received, this report will be supplemented.
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