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

Model Number	NA-201SX-4022
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
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
It was reported that during an ebus (endobronchial ultrasound) procedure for a diagnostic transbronchial biopsy using a single-use aspiration needle, the sheath of the needle broke off and became lodged in the right main bronchus during the second puncture as the needle was being withdrawn.The procedure was prolonged by approximately five minutes due to the replacement of the ebus device with a regular broncho fiberscope and the subsequent removal of the element from the bronchus.The sheath was removed with forceps, and the bronchial tree was examined, with no other foreign bodies found.Due to the situation, the single use aspiration needle was not used further and the procedure was completed with use of a similar device.In addition, the single use aspiration needle was inspected prior to use with no abnormalities observed, and the mandrel that secures the single use aspiration needle was also examined, with no abnormalities observed.There was no report of patient injury or harm as a result of the device issue.The patient's current health status was described as significantly debilitated, with exertional dyspnea; however, there is currently no evidence to suggest that this condition was caused by the reported device issue.
Event or Problem Description
It was reported by the customer that the olympus device did not cause or contribute to the patient's current health conditions.The patient's condition is attributed to existing medical issues, including multiple comorbidities and lung cancer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the final investigation and device evaluation.Additionally, to provide an update to the following fields: b5, b7, d8, d9, and h3.The device was evaluated by olympus, and the coil was confirmed detached from the sheath.Based on the results of the investigation, it is likely that the reported event occurred due to the following: 1.The tip of the sheath is pressed against the tissue of the trachea, bronchi, esophagus, and surrounding organs.2.With the sheath pressed against the tissue, the scope is pushed in, bending the sheath and coil sheath.3.When an attempt is made to push the needle out with the sheath and coil sheath bent, the tip of the needle gets caught in the bent part of the coil sheath, making it impossible to push the needle out.4.When the needle cannot be pushed out, further force is applied in an attempt to force it out.The coil sheath also moved and detached.However, the specific root cause of the reported event could not be identified.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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22347793
• Report Number: 9614641-2025-01082
• Device Sequence Number: 17368686
• Product Code: FCG
• UDI-Device Identifier: 04953170389887
• UDI-Public: 04953170389887
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: NA-201SX-4022
• Device Lot Number: 47V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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: BRONCHOFIBRESCOPE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 66 KG