MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 7MM; SPIRATION VALVE

Model Number	SVS-V7-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had to be hospitalized for 2 weeks because of having valves put in.It was stated the patient now has two chest tubes and a hole in the chest because he ended up with a pneumothorax and they couldn't get his lungs inflated.
Additional Manufacturer Narrative
Since the model number is unknown svs-v7-00 was selected as a representative product with the same procode.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the final investigation.Updated fields: d8, g1, h2, h3, h6 and h11.The device has not been returned to olympus for evaluation.Based on the results of the investigation the root cause cannot be determined.The relationship between the device and the adverse event cannot be confirmed.The most probable cause of the complaint is cause not established.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event due to no findings available.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.

• Brand Name: VALVE IN CARTRIDGE, 7MM
• 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
• Manufacturer Contact: tood brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21413039
• Report Number: 3004450998-2025-00015
• Device Sequence Number: 18221872
• Product Code: NJK
• UDI-Device Identifier: 00896506002279
• UDI-Public: 896506002279
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: SVS-V7-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 12/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male