Olympus medical systems corp.(omsc) received a literature titled "endoscopic cystogastrostomy: still a viable option in children with symptomatic pancreatic fluid collection".The literature reported the result of pancreatic fluid collections (pfcs) patients who underwent endoscopic cystogastrostomy procedure using olympus "therapeutic duodenoscope (tjf180v)" from june 2013 to december 2017.In the literature, it was reported complication as follows; (1) pfc got infected following the procedure (2 cases); (2) significant bleeding (1 cases); (3) pneumoperitonium (1 case); (4) minor bleeding (5 cases).The literature states the following; significant bleeding which stopped spontaneously.Pneumoperitonium needed unplanned admission for 7 nights.Minor bleeding characterized by oozing from the puncture site.There are not mentioned that these complications were related to the subject device in question.However, omsc assumes that "pfc got infected following the procedure" and "pneumoperitonium" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.Therefore, omsc determined that the "pfc got infected following the procedure" and "pneumoperitonium" were adverse event to submit.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.Omsc will submit 3 medical device reports (mdr) depending on the number of events.This mdr is the second of three (pfc got infected following the procedure).
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The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.
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