MAUDE Adverse Event Report: Gyrus ACMI, Inc. ViziShot 2 FLEX; SINGLE USE ASPIRATION NEEDLE

Model Number	NA-U403SX-4019
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal tip, plastic sheath of the single use aspiration needle detached inside the patient's lung during a diagnostic ebus procedure.As a result of the event, the planned ebus sampling portion of the procedure was aborted and the patient was sent for an urgent ct chest.The detached device was subsequently retrieved.The patient remained hemodynamically stable throughout the event and was monitored for vital signs.A possible tissue injury to the patient was reported; however, no details were provided regarding the nature or extent of the 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.

• Brand Name: ViziShot 2 FLEX
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• 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 ; +1(508)207-7661
• MDR Report Key: 50576061
• Report Number: 3011050570-2026-00864
• Device Sequence Number: 10293151
• Product Code: KTI
• UDI-Device Identifier: 00821925043060
• UDI-Public: 00821925043060
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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-U403SX-4019
• Device Lot Number: KR435651
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/02/2026
• Date Device Manufactured: 03/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown