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	Abrasion (1689); Hematoma (1884)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The model number of the device was unknown, but a representative device was chosen for processing purposes.The suspect device has not been returned to olympus for evaluation.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.The literature is attached for additional information.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "aortic wall abrasion caused by needle injury after endoscopic ultrasound-guided fine needle aspiration of a mediastinal hemangioma".Literature summary: benign mediastinal cysts are challenging to diagnose.Although endoscopic ultrasound (eus) and eus-guided fine needle aspiration (fna) can accurately diagnose mediastinal foregut cysts, little is known about their complications.This paper reports a rare case in which eus-fna performed on mediastinal hemangioma resulted in an aortic hematoma.A 29-year-old female patient was commissioned for eus of an asymptomatic accidental mediastinal lesion.Chest ct revealed a 4.9×2.9×10.1 cm thin-walled cystic mass in the posterior mediastinum.Eus revealed a large, anechoic cystic lesion with a regular thin wall with negative doppler.Eus-guided fna was performed using a single-use 19-gauge aspiration needle (ez shot 3; olympus, tokyo, japan), and approximately 70 cc of serous pinkish fluid was aspirated.The patient was in a stable condition with no signs of acute complication.One day after eus-fna, thoracoscopic resection for mediastinal mass was conducted.The purple and multi-loculated large cyst was removed.Upon removal, however, an aortic hematoma caused by a focal descending aortic wall injury was observed.After a few days of close observation, the patient was discharged upon stable 3d aorta angio ct findings.This paper reports a rare and severe complication of eus-fna, in which an aspiration needle caused a direct injury to the aorta.The injection must be performed carefully to avoid damaging the adjacent organs or digestive tract walls.Type of adverse events/number of patients aortic hematoma, which was thought to have been caused by a focal descending aortic wall injury - 1 patient.There is no report of any olympus device malfunction in any procedure described in this study.
Event or Problem Description
Additional information received stating no olympus device malfunction during any procedure described in this literature.The customer does not know the serial/lot numbers of the device due to the device had been disposed after procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received through follow-up.Additional correction to the initial g2.The device history record was unable to be reviewed for this device since the serial and/or 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 events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.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): 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17015033
• Report Number: 9614641-2023-00747
• Device Sequence Number: 7538653
• Product Code: FCG
• UDI-Device Identifier: 04953170380402
• UDI-Public: 04953170380402
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151738
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/06/2023
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 29 YR
• Patient Sex: Female