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	Dyspnea (1816); Pneumothorax (2012); Wheezing (4463)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2429304-2022-00141.
Event or Problem Description
Olympus reviewed the following literature titled "rapid growth of granulation tissue: a rare cause of stridor." a 63 yo f with pmh of 20 pack year tobacco use presented for evaluation of a 2.6cm x 2.4cm rul nodule and mediastinal lymphadenopathy.She underwent navigational bronchoscopy of rul nodule and ebus-tbna for mediastinal staging.Ebus-tbna was performed using an olympus 21g needle at stations 11l, 4l, 7, 4r and 11r.She recovered post-procedure and discharged home.The following evening, she developed shortness of breath and "wheezing¿ which prompted her to report to er.On exam, she had audible inspiratory and expiratory stridor and lungs were clear to auscultation bl.Cxr showed a small right apical pneumothorax which resolved with conservative management.However, her stridor and shortness of breath was unchanged.Thus, repeat flexible bronchoscopy was performed demonstrating interval development of granulation tissue in the lower trachea and in the right main bronchus with complete obstruction of the right main bronchus.The granulation tissue formed at the tbna puncture site at stations 7 and 4r.Ultimately, the granulation tissue was excised using cryotherapy and she was given oral corticosteroids to prevent further development of granulation tissue.Type of adverse events/number of patients: shortness of breath.Wheezing.Pneumothorax.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.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.Olympus will continue to monitor field performance for this device.

• 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: 15880865
• Report Number: 9614641-2022-00673
• Device Sequence Number: 5399053
• Product Code: FCG
• UDI-Device Identifier: 04953170180958
• UDI-Public: 04953170180958
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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
• 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: 10/31/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/19/2022
• 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; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female