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 Codes	Obstruction/Occlusion (2422); Cholangitis (4821)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The literature described "ez shot 3 plus"; therefore, "na-u200h-8019" was selected as a representative device for patient identifier (b)(6).The suspect device has not been returned to olympus for evaluation.The root cause could not be identified.A causal relationship between the patient's symptoms and the device could not be determined from the literature.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.Based on the results of the investigation, no defects related to the device were noted in the literature.The literature article is attached for additional information.
Event or Problem Description
Olympus reviewed the following literature titled "preliminary feasibility study of a new partially covered self-expandable metal stent with an anchoring flange for eus-guided hepatic gastrostomy (with videos)".Two patients developed cholangitis after eus-hpg and seven patients developed recurrent biliary obstruction (rbo).Cholangitis was managed successfully by conservative treatment.No severe adverse events (including bile peritonitis and proximal or distal stent migration) were observed.Endoscopic reintervention for rbo was successfully performed using a duodenoscope in a retroflex position in all patients (7/7) through the stent.Four patients with rbo because of sludge formation, stent cleaning by balloon sweeping was performed with placement of an additional 7f plastic stent in 3 patients.Two patients with hyperplasia, stent-in-stent deployment of uncovered metal stents was performed.One patient with nonocclusive cholangitis, additional antegrade metal stent placement was performed.This medwatch requires two reports.The related patient identifiers are as follows: (b)(6) gf-uct260; evis lucera ultrasound gastrovideoscope (b)(6) na-u200h-8019; single use aspiration needle na-u200h.This medwatch represents (b)(6).

• 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: 18351062
• Report Number: 9614641-2023-01939
• Device Sequence Number: 20400346
• Product Code: FCG
• UDI-Device Identifier: 04953170380402
• UDI-Public: 04953170380402
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2023

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown