The subject device has not been returned to olympus medical systems corp (omsc) for evaluation.Since the lot no.Is unknown, the manufacturing history record (dhr) could not be reviewed.However, omsc has only shipped devices which passed the inspection.There was no malfunction report of the subject device concerning the events.The exact cause of the reported event could not be conclusively determined because the subject device was not returned omsc for evaluation.
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On february 13th, 2020, olympus medical systems corp.(omsc) received a literature titled ¿impact of electrical pulse cut mode during endoscopic papillectomy:pilot randomized clinical trial¿.The literature reported results of the sixty procedures of endoscopic papillectomy using an olympus disposable electrosurgical snare between april 2016 and april 2018.Nine cases of procedure-related delayed bleeding were reportedly observed.The delayed bleedings were stopped using a non-olympus hemoclip (resolution, boston scientific (b)(4)).The relationship between the subject device and all of the reported complications could not been determined based on the available information.According to the number of the complications and the number of olympus device which mighty have contributed to the complications, omsc is submitting nine medical device reports.This is one of nine reports.
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