MAUDE Adverse Event Report: GYRUS ACMI, INC. SINGLE USE ASPIRATION NEEDLE; BRONCHOSCOPE ACCESSORY

Model Number	NA-403D-2021
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Related patient identifier: (b)(6).The evaluation of the event 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 the aspiration needle could not be inserted to the end.The malfunction occurred during a diagnostic procedure for aspiration biopsy when used in combination with the guided sheath.The physician used a different aspiration needle which could be inserted; however, the needle did not come out of the tip.The procedure was completed using biopsy forceps.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection, and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: a hole detected on the side at distal end of sheath.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: the most probable cause for the malfunction was due to a component failure.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information provided by the customer.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19187235
• Report Number: 3011050570-2024-10080
• Device Sequence Number: 7413032
• Product Code: KTI
• UDI-Device Identifier: 00821925042513
• UDI-Public: 00821925042513
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171232
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NA-403D-2021
• Device Lot Number: KR383800
• 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: 03/27/2024
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• 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: SG-200C GUIDED SHEATH
• Patient Sex: Unknown