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

Model Number	NA-403D-2021
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a radial-ebus therapeutic procedure, it was difficult to get the aspiration needle in and still difficult to get it out and the guidesheath of the needle had stretched during insertion or withdrawal.The procedure was delayed and completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
Additional Manufacturer Narrative
Updated fields: d9,h3, h4, h6, h10, h11 investigation findings code on initial should been - c21.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.Based on the results of the investigation, the most probable cause of the findings is component failure.The evaluation also identified additional findings of kinks in the insertion portion, missing stopper/stylet knob.A review of the device history record found no deviations that could have caused or contributed to the issue.Based on the results of the investigation, the definitive root cause of the issue could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that during a radial-ebus therapeutic procedure, it was difficult to get the aspiration needle in and still difficult to get it out and the guidesheath of the needle had stretched during insertion or withdrawal.The procedure was delayed and completed with a similar device.There were no reports of patient harm.

• 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: 19378770
• Report Number: 3011050570-2024-10123
• Device Sequence Number: 12688629
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: KR373809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown