The device was returned to olympus medical systems corp.(omsc) for evaluation.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Omsc confirmed the device, and could duplicate the user¿s report.The exact cause was unknown; however, omsc assumed a potential cause as follows.Because the user forcibly insert or withdraw the device into the bending section of the endoscope with the bending section bent, the distal tip of the device was broken and ultrasonic propagation fluid coming out of the distal tip of the device.Because during probe rotation, the user forcibly insert or withdraw the device into the endoscope, the distal tip of the device was broken and ultrasonic propagation fluid coming out of the distal tip of the device.The instruction manual provides preventive measures against the reported failure mode.
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