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

Model Number	NA-403D-2021
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
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 during transbronchial lung biopsy procedure, no sample could be obtained with a biopsy or cytology brush.Consequently, the customer opted to use this aspiration needle; however, the needle did not come out and the test ended.Additionally, as the patient's condition "not being good and it was taking time," the procedure was discontinued.As reported, no additional biopsies will be performed, and a scheduled operation on august 30th was not performed, as a result.There were no reports of patient injury.
Event or Problem Description
Additional information received from customer that the change in health condition was not caused or contributed by the reported device issue.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer and the results of the legal manufacturer's final investigation.Updated fields: b5, d8, h3, h4, h6.The device was returned to olympus for inspection and the reported failure was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.During the device evaluation: the shaft was bent and was deformed, longitudinal abrasions were observed on the surface of the deformed sheath and stretching was observed in the deformed sheath.Based on the results of the investigation, the needle did not come out due to a component failure of sheath.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• 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: 20140202
• Report Number: 3011050570-2024-10328
• Device Sequence Number: 12616837
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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-403D-2021
• Device Lot Number: KR315702
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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: BF-P290; K-201
• Patient Sex: Unknown