The following events were reported in the endoscopica digestiva vol.30 no.4 2018.Article title: techniques for safely performing duodenal esd < summary> kd-650q and/or kd-620qr were used in the study of treatment outcome comparing the pocket-creation method (pcm group) and conventional endoscopic submucosal dissection (conventional method: cm group).The total cases were 45 which were performed from 2006 to 2015.In the study, accidental symptoms occurred as follows.The number of accidental symptoms were calculated by multiplying the total cases by the incidence rate.Pcm group: perforation 7% (2 cases), postoperative bleeding 4% (1 case).Cm group: perforation 29% (5 cases), postoperative perforation 6% (1 case), emergency operation 6% (1 case), postoperative bleeding 18% (3 cases).The malfunction of the subject device has not been reported.This report is regarding kd-620qr, cm group, postoperative bleeding 1 of 3 cases.
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This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, omsc could not evaluate the reported device.The exact cause of this issue could not be conclusively determined.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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