Model Number NA-U200H-8022 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Pancreatitis (4481)
|
Event Date 02/04/2022 |
Event Type
Injury
|
Event Description
|
It is reported in the literature titled: "a case of high grade pancreatic intraepithelial neoplasia diagnosed by endoscopic ultrasound-guided fine needle aspiration, " the patient experienced mild pancreatitis.This literature is a case report of high grade pancreatic intraepithelial neoplasia diagnosed by endoscopic ultrasound-guided fine needle aspiration (eus-fna).The patient was a (b)(6) man who came for a checkup.Main pancreatic duct (mpd) dilatation was observed on abdominal ultrasonography.His tumor marker levels were normal.Contrast-enhanced computed tomography showed a dilated caudal mpd and pancreatic parenchyma atrophy, consistent with the interruption of the mpd in the pancreatic body.Magnetic resonance cholangiopancreatography revealed caudal mpd dilatation and a small cystic lesion around the mpd stenosis.Endoscopic ultrasound (eus) showed a faint 10-mm hypoechoic area around the pancreatic duct with indistinct borders, irregular contours, and heterogeneous internal echogenicity.High grade pancreatic intraepithelial neoplasia or minimally invasive carcinoma was suspected.Endoscopic pancreatography revealed a 20-mm stenosis in the mpd; endoscopic nasopancreatic drainage and subsequent pancreatic juice cytology were performed.All samples were classified as class iii.Eus-fna was performed to evaluate the faint hypoechoic area in order to exclude malignancy.Four punctures were performed using ez-shot3 plus22g the patient developed mild pancreatitis that improved with conservative treatment.There is no report of olympus device malfunction.
|
|
Manufacturer Narrative
|
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information was added to the following fields: b3, h6, h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|