It was reported, that an issue was discovered, during the preparation for an unspecified procedure.And the procedure was completed without delay, using the same device.
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This report is being supplemented to provide additional information, based on the device evaluation and 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 ten (10) years, since the subject device was manufactured.The device was returned, and an evaluation was completed for it.During the inspection, olympus confirmed, the reported event: the front connection where the scope goes in is loose.The scope detection slide is not functioning.Additionally, it was found, that the front panel blinks constantly (intermittently).Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely, that the front panel was blinking constantly (or intermittently), due to an output connector failure.In addition, the locking mechanism and slide detector were not functioning properly.Olympus will continue to monitor field performance for this device.
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