This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct d5.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, root cause could not be identified although it can be presumed it was due to stress of repeated use, external factors or handling of the device, the image sensor unit was damaged such as disconnection or a part mounted on the electrical circuit board such as integrated circuit chips and capacitors was broken.The events can be detected/prevented in accordance with the following instructions for use: chapter 3 ¿preparation and inspection¿, section 3.8 ¿inspection of the endoscopic system¿ olympus will continue to monitor field performance for this device.
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