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 Code	Pneumothorax (2012)
Date of Event	02/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
Olympus reviewed the literature titled ¿the vanishing lesion: a procedural clue to pneumothorax during endobronchial ultrasound¿.Literature summary endobronchial ultrasound (ebus) has become an essential tool in lung cancer staging and the diagnosis of centrally located pulmonary lesions.Vigilance during ebus-guided biopsy is crucial.The disappearance of a previously visualised lesion should raise suspicion of a developing pneumothorax.The literature highlights the experience with an intra-procedural pneumothorax following ebus-guided biopsy and discuss the procedural considerations relevant to its prompt recognition and management.Methods this is a single-patient case report describing a 52-year-old woman undergoing endobronchial ultrasound (ebus)¿guided procedures for evaluation of a right upper paratracheal lung lesion.The procedure included ebus-guided transbronchial needle aspiration (ebus-tbna) followed by an attempted ebus-guided cryobiopsy.An electrocautery knife was used to create a tract for cryoprobe insertion.Radial ebus and fluoroscopic guidance were later used for transbronchial lung cryobiopsy, with post-procedure imaging to assess complications.Results: after initial visualization of the lesion on ebus, the lesion suddenly disappeared upon reinsertion of the scope.Subsequent radial ebus-guided cryobiopsy successfully obtained tissue, confirming lung adenocarcinoma with egfr exon 19 deletion.Post-procedure chest radiography revealed a right-sided pneumothorax with subcutaneous emphysema, requiring urgent chest tube insertion.The patient recovered fully and was discharged after lung re-expansion.Retrospective review suggested the pneumothorax likely occurred intra-procedurally, most plausibly related to use of the electrocautery knife.Conclusion: the authors conclude that the sudden disappearance of a lesion during ebus should immediately raise suspicion for pneumothorax, even in the absence of obvious ventilatory or hemodynamic changes.Type of adverse events/number of patients: right-sided pneumothorax and subcutaneous emphysema in a 52 years old, female patient.There was no allegation of device malfunction identified in the article.This report is 1 of 2.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer's investigation.The device has not been returned to olympus for evaluation.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Should additional relevant information become available, a supplemental report will be submitted.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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 25058735
• Report Number: 9614641-2026-00465
• Device Sequence Number: 15987612
• Product Code: FCG
• UDI-Device Identifier: 04953170388323
• UDI-Public: 04953170388323
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BF-UC190F BRONCHOVIDEOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female