MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 9MM; SPIRATION VALVE

Model Number	SVS-V9-00
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the lot number remains unconfirmed.The company representative indicated that the lot number is possibly ws487109.D6a: the valve was implanted on (b)(6) 2024.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 a bronchoscopy, the physician noted difficulty removing two endobronchial valves.The valves had been implanted for the management of an air leak and were being removed after resolution of the air leak.According to the report, the physician was unable to locate the valves due to surrounding lung tissue, and it was suspected that scar tissue had formed over the device.As a result, the valves could not be removed and remained in the patient.A chest x-ray was performed and confirmed that the valves remained appropriately positioned within the lung with no evidence of movement.No contrast dye was utilized.There were no patient complications associated with the unsuccessful removal attempt.There are currently no plans to pursue additional removal efforts, and the patient remains clinically stable.There were no reports of patient harm.This report is 2 of 2.
Event or Problem Description
No additional information was received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: e1, d10, h6, h11.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: VALVE IN CARTRIDGE, 9MM
• Common Device Name: SPIRATION VALVE
• Manufacturer (Section D): GYRUS ACMI, INC.; 6675 185th ave ne; redmond WA 98052
• Manufacturer (Section G): GYRUS ACMI, INC.; 6675 185th ave ne; redmond WA 98052
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23612270
• Report Number: 3004450998-2025-00069
• Device Sequence Number: 13212828
• Product Code: NJK
• UDI-Device Identifier: 00896506002309
• UDI-Public: 896506002309
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: SVS-V9-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 17 YR
• Patient Sex: Unknown