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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On sep.2, 2021, olympus medical systems corp.(omsc) received the literature titled "predictive factor of recurrence after endoscopic papillectomy for ampullary neoplasms".This study was conducted for 96 patients with ampullary neoplasms who underwent endoscopic papillectomy (ep) from january 2000 to october 2018.The median age of the patients was 69 years (range, 20-89 years), and 49 patients were men.In the literature, it was reported that the following.Bleeding, pancreatitis, cholangitis, stent migration occurred in 6, 4, 3, and 2 patients, respectively.Pancreatitis was with new or prolonged hospitalization.An endoscopic retrograde cholangiopancreatography(ercp) was performed before the ep.Ercp was performed using a duodenoscope (tjf-240 or tjf-260v).Ep was performed using a crescent electrosurgical polypectomy snare (sd-5u-1) without a prior submucosal injection.Placements of both biliary and pancreatic stents which the manufacturer was unknown were routinely attempted after ep.Based on the available information, reported bleeding, pancreantis, and cholangitis were not reported in a direct relationship with the olympus products.However, omsc assumes that the pancreatitis might be related to the subject device since the subject device was used for the procedure.And, omsc assumes that the pancreatitis might be caused or contributed to a death or serious injury.Therefore, omsc assumes that the pancreatitis was an adverse event to submit.Based on the available information, specific information on the subject device and the patient (except for some, for example, age) were not provided.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) of the subject device for the pancreatitis.
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