This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, olympus could not conclusively specify root cause of the suggested event.The event can be detected and prevented in accordance with the following ifu.¿ 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 leading to fluid invasion into the endoscope.¿ do not bend the insertion section of the endoscope forcefully.Insertion section damage may result.Chapter 7 cleaning, disinfection, and sterilization procedures 7.5 manual cleaning brushing the channel gently withdraw the single-use channel cleaning brush (bw-201b) from the suction cylinder opening part.Make sure that the shaft does not rub against the external opening of the suction cylinder.If the shaft was rubbed strongly against the cylinder opening part, the shaft may be scraped.This could allow shavings enter inside the tube.If cleaning is performed according to this instruction manual, shavings will not remain in tubes.Olympus will continue to monitor field performance for this device.
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