This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number 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 evaluation found leak on the biopsy channel and foggy image.The root cause of the reported issue was not identified.It was reported that during reprocessing the device instrument port came out.It was presumed that the issue have occurred due to external force being applied.The manufacturing date of the current product was june 10, 2013, which has passed for more than 7 years, it was considered that the issue have occurred due to device age deterioration.Olympus will continue to monitor complaints for this device.
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