This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.This device was manufactured by cybersonics inc in january 2015.Partial dhr records were provided to olympus for review.Partial records do not include packaging or labeling operations for this reason a final manufacture date not available.The device had been previously serviced by olympus therefore a service history review will replace dhr review.This device has undergone multiple inspections as being asset returns.This device was previously inspected by olympus on october 13, 2020 (ds# (b)(4)).At that time, minor scratches and dings on the housing were observed.The unit passed functional test, output test and electrical safety test.Since the user did not report any problems and the damage was found during device inspection, it is likely the problem happened during transit due to improper handling such as dropped package.The device ifu states "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage," (page 1).
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