There is no additional information available for this event.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.The user¿s complaint was confirmed.The device history record review confirmed that device there were no abnormalities, special adoption, or variations in manufacturing.The device shipping was normal.Upon inspection and testing, it was observed that the device shook violently due to probe body twisted in the middle and the probe tip is deformed.The cause of this issue is not related to manufacture or development of device.Possible cause for the issue could be that an external force was applied to the sheath of the insertion section or the sheath of the tip while the actual product was driving, and the sheath and the internal blade were engaged and twisted.However, the root cause for the issue could not be conclusively determined.Instructions for use (ifu) for preparation and inspection, inspection of the endoscopic system, include statements as below: do not place the ultrasonic probe in unclean environment.This could result in injury and pose an infection control risk.To prevent damage to the ultrasound center and/or the probe driving unit, make sure that the ultrasound center is turned off before connecting or disconnecting the ultrasonic probe to the probe driving unit.Never disconnect the ultrasonic probe from the probe driving unit when using real-time mode (i.E., while the ultrasonic transducer is rotating).This could result in damage to the ultrasonic probe and/or probe driving unit.
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