The subject device in this report has not been returned to omsc for evaluation.The malfunction of the subject devices concerning this case has not been reported.Also, since the serial numbers of these devices are unknown, omsc could not confirm the manufacturing history.The exact cause of the reported event could not be determined.
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Olympus medical systems corp.(omsc) received a literature titled ¿current status in ercp procedure using balloon assisted endoscopes for reconstructed intestine¿ that was made in public in the 95th congress of the japan gastroenterological endoscopy society.The literature reported that the result of questionnaire survey for 161 cases of endoscopic retrograde cholangiopancreatography (ercp) procedure using a balloon endoscope for reconstructed intestine conducted at 13 facilities.It was reported that accidental symptoms occurred in 30 cases; 14 cases of pancreatitis, 9 cases of cholangitis, 6 cases of perforation, and one case of cholecystitis.One case of perforation required an emergency surgery to fixit.It was also reported that olympus and non-olympus balloon assisted enteroscope were used for these procedures.Omsc reviewed the delivery history of the endoscopes for the facilities and the history revealed that olympus balloon assisted enteroscope (model name: sif-q260, sif-h290s and sif-y0004-v01) had been delivered two user facilities which were surveyed.Since there was no information on the model and manufacturer of the balloon assisted enteroscope that was used in the 30 accidental symptom cases, omsc is submitting mdrs according to the number of the scope model of olympus.This is two of three reports.
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