The subject device was not returned to olympus medical systems corp.(omsc).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, we presume that the reported accidental symptom was not due to the malfunction of the device, but occurred as a general accidental symptom of the procedure.
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The following event was reported in gastrointestinal endoscopy vol.31 no.7; title "duodenal esd (endoscopic submucosal dissection) " summary.Delayed perforation occurred in one case after duodenal esd.Any of the following devices may have been used for the procedure.*itknife, dualknifej, hookknifej or non olympus's device.After making a full-circle incision and deep cutting for the lesion, the lesion was collectively resected by snaring.The exposed blood vessels were coagulated for the purpose of preventing post-bleeding.The day after the procedure, the patient developed abdominal pain and fever.The doctor performed an endoscopy on the patient.As a result, the doctor found the delayed perforation.The patient was treated conservatively and recovered.The treatment was the following.The administration of octreotide acetate.Fasting.The administration of antimicrobial agent.No further information was provided.This is the report regarding the occurrence of delayed perforation on itknife.
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