Device was received and evaluated.Evaluation determined that the reported issue was confirmed.The device was found with a broken objective cover glass, the lens were found chipped.In addition, dirt in the objective lens were observed.Device was placed for repair.If additional information becomes available this report will be supplemented accordingly.
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This supplemental report is being submitted to provide the lot number update, review of the device history records (dhr) investigation conclusion and to inform that this report is a duplicate of patient identifier (b)(6).Mfr 1519132-2020-00100.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.Based on the device evaluation results, physical damages to 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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