This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: b5, h4, h6, h10.Corrected fields: e2, e3, g2.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation and the information provided, it could not be determined what the foreign material was.There was no damage to the area where the foreign material was detected, and it was unknown if reprocessing was performed according to the instructions for use (ifu).Therefore, the cause of the material remaining in the device could not be determined.As a result of confirming contents of instruction manual at the time of shipment of the product, there are following descriptions.Chapter 7 cleaning, disinfection, and sterilization procedures chapter 8 reprocessing workflow for endoscopes and accessories chapter 9 reprocessing the endoscope (and related reprocessing accessories) olympus will continue to monitor field performance for this device.
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