This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected field: b5 (common device name corrected).Additional information added to fields: h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over twelve (12) years since the subject device was manufactured.Based on the results of the investigation, it is likely the following led to the malfunction: it is presumed that the defect was caused by stress of repeated use, external factors, or handling.However, the root cause could not be specified.The event can be detected by following the instructions for use: chapter 3 preparation and inspection, 3.2 preparation and inspection of the endoscope.Olympus will continue to monitor field performance for this device.
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