This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Correction to d4.The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The guidewire tip was torn.The fracture shape suggests a brittle fracture.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a likely mechanism causing the reported event might be the following: 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 detected/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 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.When using a guidewire, insert this product into the forceps plug of the endoscope while holding the tip as shown in figure 4.20 and aligning the tip with the guidewire.As shown in fig.4.21, do not insert the tip at a large angle between the guide wire.Doing so may damage the guidewire tip and prevent insertion along the guidewire".Olympus will continue to monitor field performance for this device.
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