The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, water tightness not maintained due to holes in the forceps channel, liquid leakage observed in the light guide bundle, stickiness due to water leakage observed on the operation part, leakage observed on the up/down plate, and leakage found on the universal cord.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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This report is being supplemented to provide additional information based on 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.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to incorrect or insufficient reprocessing or handling.It is suggested that the user facility review operating environment, reprocessing and handling of the device.Olympus will continue to monitor field performance for this device.
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