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

Model Number NA-403D-2021

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

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 any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the single use aspiration needle split in two inside its guide sheath.The issue was found during an ebus (endobronchial ultrasound) bronchoscopy procedure.The needle was cleaned as much as possible with enzymatic soap and cidex but there was still a little blood inside the guide sheath.There were no reports of patient harm.This report is related to the following linked patient identifiers: (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation with correction to the initial with information inadvertently left out (b5 and g2).Additionally, to provide a correction to the initial (d9, e2, and h8) and to provide an update to fields (h3 and h4).The device was evaluated by olympus, and it was discovered that the subject device has breaks along the insertion section.Additionally, noting the two breaks closer to the handle impedes the retraction process.Correction to the initial e2 as it is unknown if the reporting resource is a healthcare professional or not.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the reported malfunction occurred due to the needle was entered into the endoscope deformed, and an attempt to straighten is caused it to break.However, the root cause of the reported malfunction could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that the device malfunction occurred in the middle of the procedure and the procedure was extended for an unspecified amount of time.The procedure was completed using another device.Additionally, per the customer there was less likely diagnosis.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: 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: 18264999
• MDR Text Key: 329674457
• Report Number: 3011050570-2023-00209
• Device Sequence Number: 1
• Product Code: KTI
• UDI-Device Identifier: 00821925042513
• UDI-Public: 00821925042513
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K171232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-403D-2021
• Device Lot Number: KR371646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1