The device was returned for evaluation and the customers allegation was confirmed.It was noted that blurred image occurred due to air bubbles at the tip due to occurence of the hole in the sheath.There is a hole in the apical sheath.Additionally, there was leakage of the ultrasonic medium.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause cannot be identified.However, based on the results of the investigation, it is likely that the following led to the malfunction: image is unclear: it is presumed that the ultrasonic image resulted in an event in which the ultrasonic image could not be rendered normally because the ultrasonic medium inside the sheath leaked out due to the occurrence of a hole in the sheath at the tip, and thus the ultrasonic wave could not be transmitted normally.For air bubbles: since a hole is made in the sheath at the tip, air enters into the sheath, so even if air bubbles are removed normally, it is presumed that air bubbles are generated again.About a hole in the sheath at the tip and leakage of ultrasonic media: a perforation has occurred in the apical sheath, indicating that an impact has been applied to the apical sheath.At that time, it is assumed that the ultrasonic medium inside the sheath leaked out because the sheath at the tip was damaged, leading to a hole.This issue is addressed in the instructions for use (ifu): after checking the instructions and product labeling, there were no abnormalities that could lead to the phenomenon.Olympus will continue to monitor the field performance of this device.
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