The device was returned to olympus for evaluation where service confirmed the customer's complaint.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Additionally, there is a hole in the sheath at the tip, and there is leakage of the ultrasonic medium.Based on the results of the investigation, it is likely that the ultrasound image cannot be depicted normally because the ultrasound medium is reduced, and the ultrasound cannot be transmitted normally.Regarding the hole in the sheath, it is likely that some stress was applied to the sheath at the tip, and the sheath at the tip was damaged, leading to the puncture.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
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