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

Model Number	NA-403D-2021
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
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 that the single use aspiration needle did not slide well inside the guide sheath.It was very tight, and it was hard to get the needle in and hard to get it out.When the respiration therapist (rt) wanted to take the needle out in order to collect the sample, it did not come out because the guide sheath itself had stretched during introduction and removal.The issue occurred during a therapeutic radial ebus (endobronchial ultrasound) bronchoscopy procedure.The procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: d8, d9, d10, h3, h4, h6, h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection and the reported failure was not confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: the tube is deformed and appeared to be bunched up at proximal end where it connects to the handle.Also, there are 2 crushes, and 1 deep kink at mid-section of the working length.The needle sheath has a punched hole 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 tube is deformed and appeared to be bunched up at proximal end where it connects to the handle, 2 crushes, and 1 deep kink at mid-section of the working length, and the needle sheath has a punched hole was due to component failure olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the single use aspiration needle did not slide well inside the guide sheath.It was very tight, and it was hard to get the needle in and hard to get it out.When the respiration therapist (rt) wanted to take the needle out in order to collect the sample, it did not come out because the guide sheath itself had stretched during introduction and removal.The issue occurred during a therapeutic radial ebus (endobronchial ultrasound) bronchoscopy procedure.The procedure was completed using 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: 19538746
• Report Number: 3011050570-2024-10162
• Device Sequence Number: 14972648
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: KR315753
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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