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 7 years since the subject device was manufactured.Based on the results of the investigation, it was presumed that there was a possibility that foreign material could not be removed due to physical damage on the device and could not be removed even though correct reprocessing was conducted due to buckling of each channel and nozzle, and a gap at the insertion section and boot.The gap between acoustic lens and ultrasound probe occurred due to mishandling by the customer or wear/damage associated with an increase in usage time.The event can be prevented by following the instructions for use which state: chapter 6 compatible reprocessing methods and chemical agents chapter 7 cleaning, disinfection, and sterilization procedures in addition, as to handling of actual device, as result of confirming contents of the instruction manual, there are following descriptions.They may prevent from indicated phenomenon.[warnings and cautions] ¿do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.Olympus will continue to monitor field performance for this device.
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