The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.Omsc has shipped only the products that passed the inspection.The operator informed that there was no abnormality in the subject device.This type of the event is most likely related to an accidental symptom.Omsc presumes that the event occurred due to either following occurrence mechanism.Output setting of high-frequency cautery power supply unit was higher than necessary.Activation time was longer than necessary.The dissection was performed in the absence of enough elevating the mucosa.Activation without aspiration of bodily fluid.During activation, the distal end of endoscope was angled abruptly.The dissection was performed while the triangular tip or knife was pushed.Incising tissue too deeply.The tissue was incised and coagulated without activation.Situation of patient (organization).
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During an endoscopic submucosal dissection, the subject device was used.In the procedure, bleeding occurred, and hemostasis was performed using hemostasis forceps.The user sutured the bleeding region and completed the intended procedure.Since bleeding was discovered at a later date, an endoscopic hemostasis procedure was performed.The patient was recovered.This is the report regarding the postoperative bleeding.
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