MAUDE Adverse Event Report: CONMED AIRSEAL; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Air Embolism (1697); Stroke/CVA (1770)
Date of Event	11/20/2025
Type of Reportable Event	Death
Event or Problem Description
The sales representative reported on behalf of the customer that the device, as-ifs1, airseal ifs, 120v, was being used during a right thoracic case on (b)(6) 2025 when it was reported, ¿embolism caused a stroke¿ patient is currently in critical condition.¿.Conmed was later advised that the patient had passed away.Further assessment was requested from the reporter, and it was found that the procedure was aborted due to surgeon visualizing air within the pulmonary vein and artery as well as hemodynamic instability.The gas sensor alarm did go off, but the staff in the room cannot remember the words displayed in the error message.It is reported that the pressure of the airseal increased.Pressure was set at 5.Bottle gas was used.The surgery was 1 hour and 15 minutes.The patient had no history of sickle cell anemia, and there is no mention of pulmonary insufficiency in patient's ehr.Echocardiogram performed during admission did not identify evidence of a pfo.Patient had diagnosis of lung cancer and had recently had chemotherapy.This report is being raised due to advisement of patient death.
Additional Manufacturer Narrative
An evaluation of the returned device found that the gas connector was loose and missing the o-ring which may cause gas supply errors during use, however, the house gas connector is not used on this device.This device is used with bottle gas only and the house gas would not be used (no house gas in these surgery rooms).No evidence of mechanical failure, or calibration errors during preventative maintenance and subsequent evaluation.Air embolism is typically associated with gas entering the vascular system during surgical procedures.There is insufficient evidence to believe there was a malfunction of the airseal device that would / could have potentially caused the venous gas embolism.Possible causes include incorrect trocar placement, insufflation in non-sealed cavities, or deviation from operating guidelines.Preventative maintenance has been completed on this repair order.Repair/evaluation completed.Final test completed and met all specifications.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.The service history was reviewed and found similar repairs to this complaint.A two-year review of complaint history revealed there has been a total of 45 complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the ifu, the user is advised improper placement of the insufflation instrument could cause gas penetrating a vessel or an internal organ, resulting in gas embolisms.To reduce the risk, use a low flow rate for the first insufflation and ensure that the insufflation instrument is correctly positioned.We will continue to monitor per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, as-ifs1, airseal ifs, 120v, was being used during a right thoracic case on (b)(6) 2025 when it was reported, ¿embolism caused a stroke¿ patient is currently in critical condition.¿.Conmed was later advised that the patient had passed away.Further assessment was requested from the reporter, and it was found that the procedure was aborted due to surgeon visualizing air within the pulmonary vein and artery as well as hemodynamic instability.The gas sensor alarm did go off, but the staff in the room cannot remember the words displayed in the error message.It is reported that the pressure of the airseal increased.Pressure was set at 5.Bottle gas was used.The surgery was 1 hour and 15 minutes.The patient had no history of sickle cell anemia, and there is no mention of pulmonary insufficiency in patient's ehr.Echocardiogram performed during admission did not identify evidence of a pfo.Patient had diagnosis of lung cancer and had recently had chemotherapy.This report is being raised due to advisement of patient death.

• Brand Name: AIRSEAL
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin 10587 ; GM 10587
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23875999
• Report Number: 1320894-2025-00291
• Device Sequence Number: 9622857
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)210707
• Combination Product (Y/N): N
• Initial Reporter State: KS
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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 Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic