The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc confirmed the subject device and found that the reported phenomenon was duplicated.When it was operated according to the instruction manual, there were no abnormalities other than foreign material.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
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This report is being supplemented to provide additional information based on 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, it is likely that material has invaded the inside because a hole was formed in the tip sheath.Additionally since indentations were found on the tip sheath and a twist was generated at the sheath location, an external force was applied to the tip sheath while the internal blade was being driven, so the internal blade could not be driven normally and the sheath was opened.The sheath of the insertion part is twisted, the internal blade cannot be driven normally, and an ultrasonic image is not obtained.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "ultrasonic probe for endoscope um-s20-17s chapter 4 usage 4.2 observation of ultrasound images ¿ do not push or pull the ultrasonic probe with strong force while the ultrasonic probe is driven (freeze release state), or pull it into the curved part of the endoscope.Slowly push and pull the ultrasonic probe, especially when the endoscope is strongly curved or when the forceps are raised.Pushing and pulling with strong force or sudden movement may cause image distortion or damage to the ultrasonic probe.¿ when driving the ultrasonic probe, return the endoscope to the curvature and forceps as much as possible.Driving with a harsh probe shape may result in image distortion or damage to the ultrasonic probe." olympus will continue to monitor the field performance of this device.
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