This report is being supplemented to provide additional information based on the legal manufacturer's device evaluation and investigation.Based on the results of the device evaluation, the reported event was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, a definitive root cause of the reported event could not be identified.The suggested event is detectable by handling the device in accordance with the following section of the instructions for use: - it was confirmed that instructions, operation manual, chapter 3 ¿preparation and inspection¿, section 3.8 ¿inspection of the endoscopic system¿ describes how to inspect for the evaluated event 1.Olympus will continue to monitor field performance for this device.
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