The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.The customer reported that the damper was broken.As a result, the internal elements in the subject device had become too loose and affected the function of the internal gas compression pump.Confirming the user¿s report, during the evaluation it was discovered that the damper of the manifold unit was indeed broken.Consequently, the manifold unit could not be held firmly in place during operation.The unsecure manifold unit caused the break and deformation of the sockets on the main board.If additional information becomes available following the device evaluation, a supplemental report will be filed.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.It has been over 7 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, it was determined that the internal components were loosened, and internal gas compression pump function was affected because the damper was damaged.The loose manifold unit impacted the inner elements resulting in the breakage and deformation of sockets on the main board (rc board).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.
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