The customer's allegation was confirmed.The device evaluation found the guidewire tip torn.Based on the results of the investigation, it is likely that the following led to the malfunction: 1) an attempt was made to insert the device into the endoscope while using the guide wire.2) when the angle between the distal end and the guide wire was large as shown in the following figure, the device was inserted into the endoscope.(see fig.2) 3) a force exceeding the resisting force was applied to the guide wire tip.This caused the guide wire tip to tear.A definitive root cause cannot be identified.A device history review revealed no issues that could have caused or contributed to the reported issue.The instruction manual contains a warning to the user regarding this event.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 the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
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