MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ASPIRATION NEEDLE NA-U401SX

Model Number	NA-U401SX-4022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect - clinical code 4581 is used to code for hypoxemia.The suspect device referenced in this report has not been returned to olympus.Additional information has been requested but no information could be provided.The literature is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "retrospective study of eus-b-fna for mediastinal and paraesophageal lesions." background: endoscopic ultrasound with bronchoscope-guided fine needle aspiration (eus-b-fna) is a useful biopsy technique that is widely applicable to lesions that can be approached through the esophagus.However, they are not widely used in clinical practice.In this study, we examined the utility of eus-b-fna as a first-line biopsy technique based on the examination results of patients who underwent eus-b-fna.Methods: between april 2020 and november 2022, 45 patients (39 with mediastinal lesions and 6 with pulmonary lesions) underwent eus-bfna.We retrospectively evaluated the diagnosis rate, the presence of complications, and the retrieval rate of genetic mutations and the programmed cell death ligand 1 (pd-l1) expression in non-small cell lung cancer based on the medical records.Oxygen administration was started when spo2 fell below 90% during the examination and was increased or decreased as appropriate.Results: a specific diagnosis was made in 93.3% of the patients.Gene panel test results were available for 75% of the cases, and the pd-l1 expression was obtained in 82.4% of the cases.Complications included hypoxemia during examination in 14 cases and bleeding complications in 1 case (mild mediastinal hematoma).There was one case of complication requiring intervention after the examination.The patient came to the outpatient clinic with a chief complaint of persistent chest pain the day after the examination, and a simple ct scan of the chest revealed a lesion with a ct value of 40-45 hounsfield units in a punctured lymph node, which was diagnosed as a hematoma.Symptoms improved with symptomatic treatment alone, and ct scan 3 months later showed resolution of the hematoma.Conclusions: the diagnostic yield and safety of eus-b-fna as a first-line procedure were comparable to previous reports.Eus-b-fna is an option for lesions that can be biopsied transesophageally and is a highly useful technique for patients who are in a poor condition.Type of adverse events/number of patients: bleeding complications - 1 patient.Hypoxemia (sp02<90%) - 14 patients.This literature article requires 3 reports.The related patient identifiers are as follows: 1.(b)(6): bf-uc260fw.2.(b)(6): bf-uc290f.3.(b)(6): na-u401sx-4022.This medwatch report is for (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
Event or Problem Description
The following additional information was received from the author: there is no causal relationship between the adverse events and the olympus device.The hypoxemia was due to the patient's original condition and the bleeding complication was due to a procedural problem.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 event 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.This supplemental report includes information added to b5.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE NA-U401SX
• 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: 18172812
• Report Number: 9614641-2023-01741
• Device Sequence Number: 7687111
• Product Code: FCG
• UDI-Device Identifier: 04953170388323
• UDI-Public: 04953170388323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160098
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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-U401SX-4022
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 11/30/2023
• 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: Required Intervention
• Patient Sex: Unknown