MAUDE Adverse Event Report: GYRUS ACMI, INC. SINGLE USE ASPIRATION NEEDLE; VIZISHOT 2 FLEX

Model Number NA-U403SX-4019

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned to olympus for evaluation.The investigation is ongoing.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 that the single use aspiration needle broke off while it was used with an evis exera ii ultrasonic bronchofibervideoscope.The tip was missing and broken off when they pulled the needle out of the scope and upon pulling the scope out, they noticed the tip was in the channel.The issue was found during a diagnostic endobronchial ultrasound-guided transbronchial needle aspiration (ebus tbna) procedure.Olympus received further information indicating that the needle broke from the sheath in the patient's lymph node following 4 passes, but the operator was able to extract the needle when they pulled the entire scope out.There was a 5-minute delay with the patient under general anesthesia to retrieve the distal 11 cm of the fractured ebus-tbna needle from the patient¿s airways.The defective single use 19g ebus-tbna needle was set aside and the procedure continued and was completed with an alternative single use 19g ebus-tbna needle.The provider had the damaged needle.The corresponding scope was returned to olympus as reportedly advised since the needle tip got stuck in the channel; however, the customer noted it was unknown if the scope had a malfunction or if it had an issue.There were no reports of patient harm as positive control and direct visualization of the fractured needle was maintained at all times within the ebus scope.The related complaint with patient identifier (b)(6) reports the evis exera ii ultrasonic bronchofibervideoscope.

Manufacturer Narrative

This information was inadvertently left off from the initial mdr.

Manufacturer Narrative

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 inspection, and the following was observed: the device was confirmed to be broken (needle was broken off from the device.The broken part was measured at 113mm.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 1 year since the subject device was manufactured.Based on the results of the investigation, the reported event was likely due to forcing the device through resistance and/or angulation.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: "do not force the instrument if resistance to insertion is encountered.Confirm the endoscope is straight and in the neutral position.Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or the instrument." ¿do not angulate the bending section of the endoscope abruptly while the needle is inserted into the instrument channel of the endoscope.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.An update has been made to h3.Also, information has been added to d9 and h4.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Type of Device: VIZISHOT 2 FLEX
• 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: 18286804
• MDR Text Key: 329994800
• Report Number: 3011050570-2023-00213
• Device Sequence Number: 1
• Product Code: KTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NA-U403SX-4019
• Device Lot Number: KR232972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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
• Treatment: BF-UC180F SN: (B)(6).
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian