This is a supplemental report for mfr report # 8010047-2017-00556 to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There were no defects on the subject device.The exact cause could not be conclusively determined.However, based on the similar cases in the past, it was known that failure of energization might occur because the current density decreased due to increasing of contact area between the tissue and the subject device.Also, the contact area between the tissue and the subject device might increase since the target tissue was soaked in water, the non-grasping section was come in contact with the tissue or the grasped tissue was too much.The instruction manual of the device has already warned as follows: pulling the tissue when applying the current.This could cause patient injury such as perforations and/or bleeding.When necessary, provide treatments to prevent perforations or bleeding from occurring after the procedure.Ensure that postoperative follow-ups are performed, and confirm that no abnormalities are found in the patient.
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