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

Model Number	NA-201SX-4022
Health Effect - Clinical Codes	Dyspnea (1816); Granuloma (1876); Pneumothorax (2012); Obstruction/Occlusion (2422); Wheezing (4463)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
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.

• 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
• MDR Report Key: 15880717
• Report Number: 2429304-2022-00141
• Device Sequence Number: 16764160
• Product Code: FCG
• UDI-Device Identifier: 04953170180958
• UDI-Public: 04953170180958
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2022
• Report Date (Section F): 10/31/2022

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?: Yes
• Distributor Facility Aware Date: 10/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female