This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: h8.Additional information added to field h3,h4,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 3 years since the subject device was manufactured.Based on the results of the investigation and the information provided, the cause of the event was unable to be specified.Presumably, the defect was caused by stress of repeated use, external factors, or handling of the device.The following is included in the instructions for use (ifu): instructions, operation manual chapter 3 preparation and operation¿ section 3.6 ¿inspection of the endoscope¿ describes how to inspect for the subject event as below.Olympus will continue to monitor field performance for this device.
|