This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, the defect was possibly caused by the stress of repeated use, external factors, or handling.However, a definitive root cause could not be identified.The following is included in the instruction for use (ifu): the instruction manual ¿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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