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	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received: it was reported that the procedure performed was ebus (endobronchial ultrasound), conducted in the trachea and airways just beyond the main carina.The device was retrieved with the assistance of forceps, which added 3-5 minutes to the procedure.However, the customer noted that no additional anesthesia was required, and no adverse events or complications were reported as a result of this incident.The patient's current condition is stable, with no complications.The customer is unsure of the procedural outcome, as ebus is typically used for diagnosing and staging lung cancer, and results are not available until pathology has been reviewed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally to provide an update with information received from the customer (b5), and to provide an update to fields (h3).The subject device was manufactured on november, 2023 based on the provided 3 digit lot information.However, the exact manufacture date is unknown.The device was evaluated by olympus, and (needle breakage) has been confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the reported event occurred due to the following mechanisms.Mechanism: a bending force was applied to the needle tube when piercing the hard body tissue during the procedure.This caused the needle tube to bend excessively.When the needle slider was pulled, a force was applied to the needle tube in a direction to make it straight.This caused the needle tube to break.However, the root cause of the reported event could not be identified.The event can be prevented by following the instructions for use which state: "when inserting the instrument into the endoscope, the distal end of the needle tube may be bent.When piercing the target, confirm the distal end of the sheath and needle tube in the endoscopic field of view and/or ultrasound image while considering such bending.Otherwise, patient injury such as perforation, bleeding, or mucous membrane damage may occur.Do not try to straighten a bent or deformed needle with your hands because the needle may break.Use a spare needle instead." olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a diagnostic procedure, the tip of a single use aspiration needle broke inside the patient's lymph node.The user was able to retrieve the broken piece and the procedure was completed.There were no reports of patient harm.Additional follow-up have been requested and pending further information.

• 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: 19806578
• Report Number: 9614641-2024-01467
• Device Sequence Number: 20770865
• Product Code: FCG
• UDI-Device Identifier: 04953170180958
• UDI-Public: 04953170180958
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: 3YV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown