This supplemental report is being submitted to provide additional information.From the inspection result of the device by olympus korea co., ltd., olympus medical systems corp.(omsc) confirmed the following: -the inside of the instrument channel was corroded.-there was a leakage at the bending section rubber due to a pinhole.-there was a leakage at the instrument channel.-the inside of the device was corroded.The exact cause of the reported event could not be conclusively determined, because the device has not been returned to omsc.From the above information, there is possibility that water entered the device from the leak point and the metal inside the device was corroded.Omsc concluded that the corrosives and water then mixed into the perforated part of the instrument channel, and came out of the instrument channel at the distal end of the device.The instruction manual provides preventive measures against the reported failure mode.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.
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