This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the reported defect was confirmed.The evaluation results are as follows: all three dilator tips were broken.One dilator had a clean break about 7.5 cm from the very tip.Another dilator had a fragmented break with the tapered dilator tip.The last dilator appears to have a clean break closer to the tapered end of the device.Although the dilator damage was confirmed, none of the returned devices appeared to have any damage to the blue sheath or to the proximal end of the dilator.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, although the dilator damage was confirmed, the root cause of the reported damage is unable to be determined.This supplemental report includes information added h4.Also, an update has been made to h3.Olympus will continue to monitor field performance for this device.
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