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

Model Number	NA-403D-2021
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
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, the subject device was unable to advance the needle in the guide sheath, as if the guide sheath channel narrows.The issue was found prior to the device entering the scope/patient during a therapeutic radial endobronchial ultrasound (ebus) procedure and was completed using a similar device.No surgical delay and no patient harm was reported by the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: d8, h4 and h6 the device was not returned to olympus for evaluation; hence, the customer's allegation was not confirmed.Based on the results of the investigation, the cause was not established a device history record review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported, the subject device was unable to advance the needle in the guide sheath, as if the guide sheath channel narrows.The issue was found prior to the device entering the scope/patient during a therapeutic radial endobronchial ultrasound (ebus) procedure and was completed using a similar device.No surgical delay and no patient harm was reported by the customer.
Additional Manufacturer Narrative
The mdr supplemental report is being submitted to provide updated fields and final investigation results and to provide a correction.The device was returned for evaluation and the customer's allegation was not confirmed.A definitive root cause could not be identified.A visual inspection found no blood traces on the device, suggesting the needle may have not been used in a patient.During functional testing, the needle tip extended and retracted as expected with the smooth movement of the slider.No problem was detected.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the performance of this device.
Event or Problem Description
It was reported, the subject device was unable to advance the needle in the guide sheath, as if the guide sheath channel narrows.The issue was found prior to the device entering the scope/patient during a therapeutic radial endobronchial ultrasound (ebus) procedure and was completed using a similar device.No surgical delay and no patient harm was reported 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: 19959980
• Report Number: 3011050570-2024-10286
• Device Sequence Number: 7137167
• Product Code: KTI
• UDI-Device Identifier: 00821925042513
• UDI-Public: 00821925042513
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2024

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: KR383796
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 09/26/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/24/2024; 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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
• Patient Sex: Unknown