The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Based on evaluation performed by the local service engineer of olympus china, omsc supposed that the ccd unit did not work normally since water invasion into the subject device caused the short circuit of the ccd electrical component.The cause of water invasion is unknown.However, from the similar complaints, the broken bending tube may have damaged the covering of the bending section.Consequently it was considered that the water entered into the inside of the subject device from the damaged covering.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The instruction manual of the device instructs; warning never insert or withdraw the endoscope under any of the following conditions.Patient injury, bleeding, and/or perforation can result.While the endotherapy accessory extends from the distal end of the endoscope (except for using an ureteral access sheath).While the bending section is locked in position.
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