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

Model Number	NA-201SX-4022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 health effect appropriate term: mandibular joint dislocation and elevation of mandible the literature article is attached for additional information.Follow up is in progress to obtain additional information regarding the event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
Olympus medical systems corporaton received a literature titled "efficacy of endobronchial ultrasound-guided transbronchial needle aspiration in the diagnosis of mediastinal and hilar lesions".This study aimed to investigate the clinical efficacy of ebus-tbna in the diagnosis and differential diagnosis of mediastinal and hilar lesions.A retrospective observational study was undertaken to investigate patients diagnosed with mediastinal and hilar lymphadenopathy based on imaging at our hospital from 2020 to 2021.After evaluation, ebus tbna was used and data including the puncture site, postoperative pathology, and complications were recorded.Data from 137 patients were included in the study, of which 135 underwent successful ebus tbna.A total of 149 lymph node punctures were performed, of which 90 punctures identified malignant lesions.The most common malignancies were small-cell lung carcinoma, adenocarcinoma, and squamous cell carcinoma.Forty-one benign lesions were identified, resulting from sarcoidosis, tuberculosis, and reactive lymphadenitis, amongst others.Follow-up findings showed that 4 cases were malignant tumors, with 1 case of pulmonary tuberculosis and 1 case of sarcoidosis).Four specimens where lymph node puncture was insufficient were subsequently confirmed by other means.The sensitivity of ebus tbna for malignant lesions, tuberculosis and sarcoidosis in mediastinal and hilar lesions was 94.7%, 71.4%, and 93.3%, respectively.Similarly, the negative predictive values (npv) were 88.9%, 98.5%, and 99.2%, and the accuracy was 96.3%, 98.5%, and 99.3%.One patient had mandibular joint dislocation due to poor oxygen and intraoperative elevation of the mandible in which post reduction was successful.Intraoperative hemorrhage occurred in 1 case which was controlled with epinephrine.Type of adverse events/number of patients mandibular joint dislocation (1) elevation of mandible (1) hemorrhage (1) this literature article requires 2 reports.The related patient identifiers are as follows: ¿ ¿ (b)(6) - single-use aspiration needle (b)(6) - ultrasonic bronchofibervideoscope ¿ this medwatch report is for patient identifier (b)(6).¿ ¿ there is no report of any olympus device malfunction in any procedure described in this study.¿.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out g2.Additionally, to provide information obtained through follow up b5.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.
Event or Problem Description
The following additional information was received from the author: an olympus device did not cause or contribute to the adverse event described in the article.Also, it was confirmed that an olympus device malfunction did not occur.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• 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: 18624599
• Report Number: 9614641-2024-00222
• Device Sequence Number: 15344753
• Product Code: FCG
• UDI-Device Identifier: 04953170389900
• UDI-Public: 04953170389900
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/05/2024

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-201SX-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: 01/09/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 03/05/2024
• 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