MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 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	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Strangulation (2084)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there was no description of the device's malfunction.
Event or Problem Description
On (b)(6) 2021, omsc received the document "mediastinal hematoma following endobronchial ultrasound-guided transbronchial needle aspiration".The purpose of the literature was to discuss one of the potential hazards for this technique which is injury of mediastinal vessels.The procedure was performed using a needle (olympus; na-201sx-4022) and flexible bronchoscope for endobronchial ultrasound (ebus) (olympus; bf-uc160f-ol8).A male patient aged (b)(6) presented to our hospital with manifestations of lower respiratory tract infection including productive cough and moderate dyspnea.The patient was chronic smoker (40 pack/ year).X-ray was performed and a nodule in the right lung was incidentally discovered.Computed tomography (ct) of chest confirmed the diagnosis of solitary pulmonary nodule in right upper lobe with speculated margins, heterogenous contrast, measuring 18 ×15 ×19 mm.The literature wrote, ¿during the intervention, the operators safely sampled station 11l and while sampling station 4l, although the aortic border was clearly visible and cautiously avoided, the operators noticed disturbance in the ultrasonographic images associated with loss of relationship between aortic border and adjacent structures, also rapidly progressive swelling in the tracheal wall led to narrowing of the tracheal lumen.The procedure was terminated immediately and the vital signs of the patient were checked closely to ensure clinical stability.A white light bronchoscopy was immediately performed, confirming the presence of newly developed tracheal narrowing.Following that, an urgent ct chest with contrast was performed and showed mediastinal hematoma with no contrast leak, denoting absence of active hemorrhage (fig.1a).The patient was transmitted then to the intensive care unit to be monitored continuously.After 48 hours of continuous monitoring without complications the patient was able to be discharged.Two weeks later the ebus-tbna was repeated, during exploration of the 4l station a vascular structure caudal to the lower border of the aorta was noticed in the doppler mode (fig.1b).Sampling of the 4l station was avoided.The procedure was completed without complications and the samples were negative for malignancy.The patient underwent surgery (wedge resection with mediastinal nodal dissection) and the pathology confirmed as a nonsmall cell lung cancer not otherwise specified stage ia (pt1n0m0).¿ also, the literature wrote, ¿in our case we attribute the development of mediastinal hematoma to accidental puncture of abnormally located bronchial artery.The bleeding was suspected after a sudden disturbance of the ultrasonographic appearance of the mediastinum during sampling.According to our experience, this sudden change was noticed before in 2 cases during ebus-tbna after development of pneumothorax and we consider that this finding usually denotes a complication.¿ based on the available information, a direct relationship between the needle and mediastinal hematoma might determined.In addition, the patient required an urgent ct and was transmitted then to the intensive care unit to be monitored continuously.This is the report regarding 1 case with rapidly progressive swelling in the tracheal wall and narrowing of the tracheal lumen and developing mediastinal hematoma and bleeding.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12193773
• Report Number: 8010047-2021-09077
• Device Sequence Number: 1322991
• Product Code: FCG
• UDI-Device Identifier: 04953170381928
• UDI-Public: 04953170381928
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

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: No Information
• Device Model Number: NA-201SX-4022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/19/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR