This supplemental report is being submitted to provide review of the device history records (dhr) and.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.The root cause of the reported issue was not identified.Probable cause could be due to the weak adhesive strength of the apical region of the unit may have resulted in damage.Device was manufactured in february 27, 2012, eight years passed since manufacturing, it is possible that the failure occurred due to device age deterioration.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states : do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Olympus will continue to monitor complaints for this device.
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