This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The subject device was not returned to legal manufacture, because the device was discarded.Therefore the reported event cannot be confirmed neither the condition of the device.Based on the similar investigation results in the past, a likely cause of the guide wire tip tear might be the following reasons: 1)trying to insert the device into the endoscope while using the guide wire.2)the device was excessively angulated while inserting the guide wire into the guide wire tip.(see fig.1) 3)a load beyond the resistance strength was applied to the guide wire tip.That might have caused the guide wire tip to tear.The event can be detected and prevented by following the instructions for use which state: (drawing number:gk5909, revision number : 21) ·when using the guide wire, insert the instrument with its distal tip in parallel with the guide wire while holding the distal tip as shown in figure 4.Be careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire as shown in figure 5.This may damage the distal tip.Olympus will continue to monitor field performance for this device.
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