The customer reported that, during preparation for use, the subject device did not drive when connected to the drive unit.The subject device was sent to olympus for evaluation.During inspection and testing, a leak was found.This report is being submitted for the malfunction found during evaluation (leak).There was no harm or user injury reported due to the event.
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During inspection and testing, the tip sheath was perforated and there was leakage of ultrasonic medium.A review of the device history record found no deviations that could have caused or contributed to ultrasonic medium leaking.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the ultrasonic medium leaked due to a hole being generated in the tip sheath because of external force being applied.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "when pulling the ultrasonic probe out of the endoscope, make sure that the freeze-switch of the observation device is on (freeze-status).Pulling the ultrasonic probe while it is driven may damage the ultrasonic probe." olympus will continue to monitor field performance for this device.The reported issue (not driving) was confirmed during testing.The probe did not drive at all even when connected because there was a twist in the connection cylinder root of the insertion section sheath.Per the legal manufacturer, this device defect has no potential to cause or contribute to death or serious injury if the malfunction were to recur.
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