This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.It has been over 7 years, since the subject device was manufactured.The device was returned to olympus for inspection.And based on the results of the investigation, the suggested event was confirmed.Presumably, the issue could have occurred, due to stress of repeated use, external factors or handling of the device.Which, may have resulted in the subject event.However, the root cause could not be specified.The event can be detected and prevented, by following the instructions for use in chapter 3: ¿preparation and inspection¿: section 3.2: ¿endoscope preparation and inspection¿: which describes, how to inspect the event in question.Olympus will continue to monitor field performance for this device.
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