An endoscopic ultrasonography was performed on a patient with suspected lung cancer using evis lucera bronchofibervideoscope bf-p260f, ultrasonic probe um-s20-17s, and single use guide sheath k-201.Ultrasound endoscopic image was displayed on the monitor at the beginning of the procedure, but then became hard to see.The physician felt the endoscope was caught while withdrawing and bronchostaxis occurred.Ultrasonic probe, a part of the distal tip of um-s20-17s, was partially missing.A fragment which appeared to be the missing part of the probe inside the patient was found by x-ray and was retrieved.The fragment was about 3 cm and looked like stretched plastic.The fragment will not provided to olympus because the hospital will analyze it.The patient was transported to icu for stopping bleeding.The treatment would be successful, according to a doctor at the hospital.According to a nurse at the hospital, no abnormality was noted before the procedure.Multiple doctors set up the devices before the procedure and they felt that the probe was thinner than others.The probe in question was a brand-new and the first use.This report is for um-s20-17s.
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This supplemental report is being submitted to provide additional information.The device and single use guide sheath k-201 were returned to olympus medical systems corp.(omsc) for evaluation.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Omsc confirmed the device, and found that a part of the distal tip of the device was partially missing.Omsc confirmed the k-201, and found that there is an indentation on the distal end side.The exact cause was unknown.Omsc surmised that external force when an indentation was generated on the k-201 was also applied to the device, and the internal blade of the device could not be driven normally, so the sheath of the device was twisted and the distal tip of the device fell off.There was the possibility that the patient bleeds because the damaged distal tip of the device touched the patient's body.
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