This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the customer's complaint was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, although a conclusive root cause could not be determined, it is likely that a blurry image was displayed due to following: the entire image was blurred due to damage to the ccd unit.The entire image was blurred due to sliding error of movable l-range that occurred in the zoom scope.Blurring the entire image occurred within the allowable range.The entire image was blurred due to damage or deformation of the connector.The following information is stated in the ifu (instructions for use) which may help to prevent the issue: operation manual, inspection of the endoscopic system, operation manual, important information ¿ please read before use warnings and caution.Olympus will continue to monitor field performance for this device.
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