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	Cholangitis (4821)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).E1 - initial reporter establishment name: (b)(6).Since the literature stated "19g or 22g needle (ez shot 3 plus)", olympus selected ¿na-u200h-8019¿ as the representative model and initiated a complaint.Attempts to obtain additional information were made but were unsuccessful.The device was not returned for evaluation; therefore, a definitive root cause could not be determined.The most probable cause was not established; the investigation findings do not lead to a clear conclusion as no malfunctions of the subject device have been reported and a causal relationship between the device and the health hazards could not be established.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Olympus reviewed the following literature titled ¿transluminal antegrade drill dilation technique for hepaticojejunostomy stricture with cholangioscopic evaluation (with video)¿.Background and study aims : balloon dilation and plastic stent deployment have been performed as hepaticojejunostomy stricture (hjs) treatment techniques under endoscopic ultrasound guidance (eus).Although these techniques have shown favorable clinical results, the treatment period can be long because stent deployment is required.In addition, hjs may recur even after treatment because the scar tissue itself remains.To overcome these challenges, we developed an eus-guided antegrade drill dilation technique for treating hjs.The aim of this study was to evaluate the technical feasibility and safety of this technique in terms of the pre- and post-cholangioscopic findings.Methods: this retrospective study included consecutive patients whose conditions were complicated with symptomatic hjs between november 2022 and february 2023.Transluminal antegrade drill dilation (tad) using a novel drill dilator was attempted within 14 days after eus-guided hepaticogastrostomy (hgs).Hjs was diagnosed with cholangioscopy before tad, and resolution was evaluated after tad using cholangioscopy.Results: tad was attempted at approximately 11 days after eus-hgs.The cholangioscope was inserted successfully in all patients after this procedure.Cholangioscopy revealed stricture without evidence of malignancy in 19 patients.In the remaining three patients, stricture was not observed and these patients underwent stent exchange rather than tad.Among the 19 patients, passage of the guidewire across the hjs into the intestine was unsuccessful in four patients, and the technical success rate for this procedure was 78.9%.Tad was successful in all 15 patients in whom passage of the guidewire was achieved.Type of adverse events/number of patients: cholangitis (1 patient).Abdominal pain (2 patients).Conclusions: in conclusion, tad appears to be technically feasible and safe.

• 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: 22926525
• Report Number: 9614641-2025-01459
• Device Sequence Number: 18430997
• 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
• Report Date (Section B): 08/29/2025

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: 08/04/2025
• Initial Report FDA Received Date: 08/29/2025
• 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: E0018450AG-2; G-240-2545S; GF-UCT180; TES0025S
• Patient Sex: Unknown