This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h3, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the event reported as " the objective lens glue was peeled off" was caused by stress of repeated use, external factors, or handling of the device over time.The event can be detected/prevented by following the instructions for use which state: it was confirmed that instructions, operation manual, chapter 3 ¿preparation and inspection¿, section 3.3 ¿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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