This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Correction to e1.The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the subject event 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: "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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