The manufacturing record of the two subject devices was reviewed without irregularity.As a result of culture conducted on the two subject devices by olympus (b)(4) bacteria was not detected.Olympus (b)(4) sent the test result and the two subject device to the user facility.The exact cause could not be determined at present.Omsc is following up with the user facility to obtain additional information regarding the reported event.If significant additional information is received at a later time, a supplemental report will be followed.
|