This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr) and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Device return evaluation confirmed the reported failure as meniscus was found to be broken, causing image loss.Excessive debris under eyecup cover glass was observed.Based on device inspection results, physical damages occurred on the device were most likely due to user mishandling.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: 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.Olympus will continue to monitor complaints for this device.
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