MAUDE Adverse Event Report: GYRUS ACMI, INC. VALVE IN CARTRIDGE, 6MM; SPIRATION VALVE

Model Number	SVS-V6-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Hemoptysis (1887); Pneumothorax (2012)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reports of the following patient identifiers are linked: (b)(6).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 4 days post bronchoscopic lung volume reduction (blvr) procedure, the patient exhibited hemoptysis with right sided chest pain and was coughing up quarter size amounts of phlegm with blood.Subsequently, the patient was diagnosed with pneumothorax requiring surgical intervention 2 days after the symptoms occurred.The patient had one chest tube placement, bronchoscopy and lavage.Then the removal and replacement of chest tube was done as part of treatment process.The patient was stable and was hospitalized for recovery.There were no further reports of patient harm.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: h6 the device was not returned for evaluation; therefore, a definitive root cause could not be determined.The most probable cause was not established; the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.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, 6MM
• 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: 22120544
• Report Number: 3004450998-2025-00041
• Device Sequence Number: 4122505
• Product Code: NJK
• UDI-Device Identifier: 00896506002293
• UDI-Public: 896506002293
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PMA P180007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/05/2025

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-V6-00
• Device Lot Number: WS496388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 05/31/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AIRWAY SIZING KIT W S475889.; BALLOON CATHETER 47K.; CATHETER AND LOADER KIT W S479938.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White