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 6 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, it is likely the defect was caused due to breakage of image sensor unit including disconnection by stress of repeated use, external factors, or handling, or that the components including integrated chip and capacitor, mounted on the electric circuit board had a defect.The instructions for use states the inspection methods associated with the event in operation manual "chapter 3 preparation and inspection, 3.8 inspection of the endoscopic system".Olympus will continue to monitor field performance for this device.
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