MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U200H

Model Number	NA-U200H-8019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	11/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "a proposed algorithm for endoscopic ultrasound-guided rendezvous technique in failed biliary cannulation.¿ background: the selection of an approach route in endoscopic ultrasound-guided rendezvous (eus-rv) for failed biliary cannulation is complicated.We proposed an algorithm for eus-rv.Methods: we retrospectively evaluated consecutive eus-rv cases between april 2017 and july 2020.Puncturing the distal extrahepatic bile duct (ehbd) from the duodenal second part (d2) (dehbd/d2 route) was attempted first.If necessary, puncturing the proximal ehbd from the duodenal bulb (d1) (pehbd/d1 route), puncturing the left intrahepatic bile duct (ihbd) from the stomach (lihbd/s route), or puncturing the right ihbd from the d1 (rihbd/d1 route) were attempted in this order.Results: a total of 16 patients were included.The dehbd/d2 route was used in 10 (62.5%) patients.The pehbd/d1 route was attempted in five (31.3%) patients, and the biliary puncture failed in one patient in whom the rihbd/d1 route was used because of tumor invasion to the left hepatic lobe.The lihbd/s route was applied in one (6.3%) patient.Successful biliary cannulation was achieved in all patients eventually.The time from the puncture to the guidewire placement in the dehbd/d2 route (3.5 min) was shorter than that in other methods (14.0 min) (p = 0.014).Adverse events occurred in one (6.3%) patient with moderate pancreatitis.Type of adverse events/number of patients: moderate pancreatitis (1 patient).Conclusions: the proposed algorithm might be useful for the selection of an appropriate approach route in eus-rv.
Additional Manufacturer Narrative
Since the literature described ez shot 3 plus, olympus selected na-u200h-8019 as representative model.E1 phone number:+(b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.This report is related to the following linked patient identifiers: (b)(4).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information from final investigation.Based on the results of the investigation, since the product was not returned and literature did not contain any information regarding detailed device usage or the occurrence of health damage, and no malfunctions of the product were reported, a causal relationship between the product and health damage could not be determined.Attempts to obtain more information from the author were unsuccessful.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U200H
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20737438
• Report Number: 9614641-2024-20015
• Device Sequence Number: 20986156
• Product Code: FCG
• UDI-Device Identifier: 04953170380402
• UDI-Public: 04953170380402
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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-8019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUODENOVIDEOSCOPE (JF-260V); ULTRASOUND GASTROVIDEOSCOPE (GF-UCT260)
• Patient Sex: Unknown