This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d8, h3, h4, h6.Corrected fields: e2, e3.(added ¿health professional¿ and ¿occupation¿.Yes, and other health professionals were also added.) a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over two (2) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.The customer did not provide a cleaning disinfection and sterilization checklist, so it is unknown if there were any deviations.Whether there was deviation from ifu in reprocessing steps for the area foreign material remained or not was unknown.The event can be prevented by following the instructions for use which state: "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.
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