MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13714468
• Report Number: 8010047-2022-04186
• Device Sequence Number: 5957590
• Product Code: FCG
• UDI-Device Identifier: 04953170380488
• UDI-Public: 04953170380488
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NA-U200H-8022
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male