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.The exact cause was unknown; however, omsc assumed a potential cause as follows.The user forcibly insert or withdraw the device into the bending section of the endoscope with the bending section bent and it caused the failure.During probe rotation, the user forcibly insert or withdraw the device into the endoscope and it caused the failure.The instruction manual provides preventive measures against the reported failure mode.
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