This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the phenomenon was confirmed.However, a definitive root cause could not be determined.The event likely occurred due to stress, handling, or external factors.The suggested event is detectable/preventable by handling the device in accordance with the following ifu.Oes cystonephrofiberscope olympus cyf-5 olympus cyf-5a important information ¿ please read before use warnings and cautions ¿ do not strike the distal end of the insertion tube or allow it to strike other objects.The objective lens surface at the distal end is particularly fragile, and visual abnormalities may result.¿ do not twist or bend the bending section with your hands.Equipment damage may result.¿ do not squeeze the bending section forcefully.The covering of the bending section may stretch or break and cause water leaks.Olympus will continue to monitor field performance for this device.
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