This supplemental report is being submitted to provide the review of the device history records (dhr) and investigation.Please see updated sections: d4, g4, g7, h2, h3,h4, h6 and h10.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A root cause cannot be conclusively determined.However, in instructions for use (ifu),ways of handling which may result in the bending tube¿s damage and detailed ways of inspections are described.If the user follows the instructions about operation and inspection of the endoscope, the bending tube¿s damage can be eliminated and any abnormality can be detected safely.The probable cause for this damage is likely that there was deviation from the following description stated in ifu.Olympus will continue to monitor complaints for this device.
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