The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There was a scratch and a peeling of the coating on the probe.Also there was a buckling on the insertion portion.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.Based on the evaluation and similar cases in the past, the bleeding might not be stopped because the coating of the probe deteriorated due to a repeatedly use.In addition, it was presumed that the tissue stuck on the probe under the influence of the condition of the tissue, the energization time, or the output setting on the high frequency generator.The buckling might be caused by excessive stress applied to the insertion portion while inserting the subject device into the endoscope or reprocessing the subject device.The instruction manual of the subject device warns; do not touch the bleeding site abruptly.This could result in more-severe bleeding and puncture; do not increase over the energy selector level.This could result in bleeding and puncture; when inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve.Otherwise, the insertion portion could be damaged.
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During a polypectomy, it was informed that the doctor could not stop bleeding with the subject device.The patient was transferred to another hospital.The patient was a temporarily serious condition, but the bleeding of the patient could be stopped with the similar device in the transferred hospital.The patient already recovered.
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