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 seventeen (17) years, since the subject device was manufactured.Based on the results of the investigation, it is likely, that the malfunction was caused by stress of repeated use, external factors or handling of the device the event can be detected/prevented, by following the instructions for use, which state: chapter 3: ¿preparation and inspection¿: section 3.2; ¿preparation and inspection of the endoscope¿: describes how to inspect for the subject event.Olympus will continue to monitor field performance for this device.
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