It was observed during the device inspection, that the deflectable videoscope exhibited image color tone abnormality due to damage to the video connector, and a noisy image due to damage to the charged couple device unit in the endoscope video connector.There were no reports of patient involvement.
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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 9 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the problem is caused by damage to the image sensor unit (e.G., disconnection) or failure of mounted components (integrated circuit chip, capacitor, etc.) on the electrical board due to stress from use, external factors, or handling.The event can be detected/prevented by following the instructions for use: the inspection method for the suggested event is described in the 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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