This supplemental report is being submitted to provide the results of the manufacturer's investigation.As part of the investigation, a review of the device history record (dhr) and a review of the instructions for use (ifu) was conducted.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause could not be determined.It is likely the connector became loose and was broken due to stress applied by the user or impact with a hard object.The ifu contains the following statements that may help prevent or detect the described issue: "check the following for each connector.-the connector should be fixed firmly.-the o-rings should be free of abnormalities such as cracks, tears, or dents." olympus will continue to monitor the field performance of this device.
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