It was reported that there were bleedings of four cases after colorectal endoscopic submucosal dissections.Olympus electrosurgical knife was used during each procedure.After the procedure, bleeding occurred.The user performed the hemostasis treatment.There was no patient injury reported except the event.No further information was reported.Based on the reported information, there is a possibility that either kd-650 or kd-612 was used.This mdr is about the second of the four cases reported.
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The subject device was not returned to olympus medical system corp.(omsc).Therefore, omsc could not evaluate the reported device.The exact cause of this issue could not be conclusively determined.Since the lot no.Is unknown, the manufacturing history record could not be reviewed.However, omsc has only shipped devices which passed the inspection.From the reported information, it is assumed that the event did not occur due to malfunction of the device, but occurred as a general accidental symptom of the procedure.
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