The subject devices have not been returned to omsc.Omsc could not review service and manufacturing records because the serial numbers of the subject devices were not provided from the facility.As part of our investigation, omsc reviewed all of the complaints for the period, but there was no record associated with the event described in the article.The exact cause of the reported event could not be conclusively determined.
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Olympus medical systems corp.(omsc) received a literature titled
¿initial results of introduction of short type balloon endoscope for postoperative reconstruction ercp case in our hospital¿.The literature reported the result of 8 cases of the endoscopic retrograde cholangiopancreatography (ercp) procedures for patients with postoperative intestinal reconstruction using olympus small intestinal videoscope model sif-h290s.In the subject cases, 3 cases of pancreatitis and 3 cases of hyperamylasemia occurred.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.Omsc is submitting three mdrs according to the number of the complication case.This report is the 1st of 3 cases and corresponds to pancreatitis.
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