This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to fields h2, h3, h4 and h6.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 since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, it is likely the following led to the malfunction: -when using the guide wire, the angle between the distal end and the guide wire was large as shown in the following figure, an attempt was made to insert the device into the endoscope.-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 detected and prevented by following the instructions for use: gk5911, revision number 22: 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 4.20.Be careful not to forcibly insert the instrument with a sharp angle between the distal tip and the guide wire as shown in figure 4.21.This may damage the distal tip.Olympus will continue to monitor field performance for this device.
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