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 inside a plastic bag with none of the original packaging.The device was removed from the bag and inspected.The dilator was inserted into the blue sheath, the tip of the dilator appeared to have been fractured.The tip appeared to have been fragmented.None of the fragments were returned.The dilator was removed from the sheath and it was extremely brittle, towards the tip, the dilator was broken when attempted to be bent slightly.The reportable malfunction was confirmed.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 formal investigation, the root cause was found to be embrittlement and degradation of the dilator polymer due to variable storage methods and environment exposure in health care facilities.As a result, the uropass device shelf life was reduced from 60 months to 30 months in 2019.Given the result of the previous dilator break investigation and given the result of this complaint¿s investigation, particularly the fact that the part in question was expired at the time of the incident, this root cause cannot be confirmed.Olympus will continue to monitor field performance for this device.
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