This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was returned to olympus for evaluation where service confirmed the customer's complaint.The black tip of the obturator was broken and missing.No additional defects/failures were noted.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Dhrs provided do not include packaging or labeling operations.For this reason, the final manufacture date is november 2017.Based on the results of the investigation, a definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects." (warnings, page 4) olympus will continue to monitor the field performance of this device.
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