This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to fields d8, 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 eight (8) years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's reportable malfunction was confirmed.Based on the results of the investigation, it is not known why the issue occurred.After reviewing the instructions manual, there were no descriptions found that relate to the event in question.Instructions oes cystonephrofiberscope olympus cyf-5 olympus cyf-5a 6.5 eto gas sterilization ¿ attach the eto cap to the endoscope connector before sterilizing.If the eto cap is not attached on the endoscope during sterilization, the vacuum created within the sterilization chamber can rupture the covering of the bending section.Olympus will continue to monitor field performance for this device.
|