This report is being supplemented to provide additional information based on the subject device was returned to an olympus service center for evaluation.During inspection and testing, service was not able to confirm the customer's reported issue regarding brown liquid flowing out from the tip of the device.There was no brown liquid or dry residue on the distal end or the instrument channel.Service did confirm there was an air leak at the forceps outlet due to a pinhole in the instrument channel.When the instrument channel was checked, there was a piece hanging inside, which was caused by scratching within approximately 10mm from the distal end.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the investigation, although it was confirmed that there was an air leak in the instrument channel, the root cause of how the suggested liquid came out could not be determined.It is possible that the liquid that leaked out of the pinhole of the instrument channel temporarily flowed out of the pinhole of the instrument channel to the forceps outlet.In addition to the pinhole in the forceps channel, service found the bending angle was insufficient due to elongation of the angle wire.Per the legal manufacturer, this issue has no potential to cause or contribute to death or serious injury if the malfunction was to recur.Olympus will continue to monitor field performance for this device.
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