This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Correction to h6 component code: 919 - processor does not apply to this event.An olympus field service engineer (fse) was dispatched to the user facility and the customer's allegation of a1 port broken was confirmed.The a1 connector in the basin became loose from connecting, disconnecting and movement of the connecting tube from side to side.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the user hit the connector with something hard or stress to the connector toward loosening direction was accumulated, leading to breakage of the connector.However, root cause of the suggested event could not be identified.The event can be detected/prevented by following the instructions for use which state: chapter 5 inspection and preparation before use 5.6 inspecting the connectors check the following for each connector.- the connector should be fixed firmly.- the o-rings should be free of irregularities such as cracks, tears, or dents.If any irregularity is found, do not use the reprocessor and contact olympus.Do not use the equipment if any connector seems to be damaged or defective.Using the equipment when an irregularity has been detected may interfere with reprocessing.Furthermore, fluid leakage may damage peripheral devices or facilities near the equipment.Olympus will continue to monitor field performance for this device.
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