This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year (3 months) since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's allegation regarding guidewire tip torn was confirmed.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be: 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.3) a force exceeding the resisting force was applied to the guide wire tip.This caused the guide wire tip to tear.The event can be prevented by following the instructions for use which state: "when using the guide wire, insert the instrument with its distal tip in parallel with the guide wire while holding the distal tip.Be careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire.This may damage the distal tip." olympus will continue to monitor field performance for this device.
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