MAUDE Adverse Event Report: CONMED AIRSEAL; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
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 an unknown procedure on (b)(6) 2026 when it was reported, "airseal dumped pressure after "venting valve error" message, resulting in an instrument burn of the aorta".Further assessment was requested from the reporter; however, to date, no answers have been received.There was no report of medical intervention or hospitalization of the patient.This report is being raised due to the reported injury of burn to aorta due to loss of pressure.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.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 an unknown procedure on (b)(6) 2026 when it was reported, ¿airseal dumped pressure after "venting valve error" message, resulting in an instrument burn of the aorta.¿.Further assessment was requested from the reporter; however, to date, no answers have been received.There was no report of medical intervention or hospitalization of the patient.This report is being raised due to the reported injury of burn to aorta due to loss of pressure.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.The service history review cannot be conducted as a serial number was not provided.A device history review (dhr) cannot be conducted as a serial number was not provided.A two-year review of complaint history revealed there has been a total of two complaints, regarding two 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 instructions for use, the user is advised that < 5 bar/73 psi; if insufflation is started, the warning message ¿change gas bottle!¿ is displayed and acoustic signals (beeps) are emitted.The gas bottle should be changed immediately.If insufflation is stopped, the warning message ¿change gas bottle!¿ is displayed and insufflation cannot be restarted.Smoke evacuation level will switch to low until tank is replaced.While in airseal mode, a countdown of 100 s is displayed during which the empty gas bottle can be changed while maintaining abdominal pressure insert obturator in airseal cannula to maintain pressure with normal insufflation.Change the tube set to finish the procedure.Avoid device overheating.Ensure free air circulation especially to the bottom and rear of the device.We will continue to monitor per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
Update for device return, correction to d4, d9, h2, h3, h4, h6.The device was not overdue for preventative maintenance.The device had a small leak at the high-pressure valve, valve block needed to be replaced and the compressor needed to be refurbished.Additionally, the angel connector was also found to be leaking, requiring replacement.A root cause cannot be determined; however, based on the evaluation of the device the likely cause of this event was an air leak resulting in the loss of cavity pressure.The service history was reviewed, and no prior data was found.A device history review (dhr) was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of two complaints, regarding two 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 instructions for use, the user is advised that < 5 bar/73 psi; if insufflation is started, the warning message ¿change gas bottle!¿ is displayed and acoustic signals (beeps) are emitted.The gas bottle should be changed immediately.If insufflation is stopped, the warning message ¿change gas bottle!¿ is displayed and insufflation cannot be restarted.Smoke evacuation level will switch to low until tank is replaced.While in airseal mode, a countdown of 100 s is displayed during which the empty gas bottle can be changed while maintaining abdominal pressure insert obturator in airseal cannula to maintain pressure with normal insufflation.Change the tube set to finish the procedure.Avoid device overheating.Ensure free air circulation especially to the bottom and rear of the device.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 an unknown procedure on (b)(6) 2026 when it was reported, ¿airseal dumped pressure after "venting valve error" message, resulting in an instrument burn of the aorta.¿ further assessment was requested from the reporter; however, to date, no answers have been received.There was no report of medical intervention or hospitalization of the patient.This report is being raised due to the reported injury of burn to aorta due to loss of pressure.

• 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: 24363486
• Report Number: 1320894-2026-00032
• Device Sequence Number: 13233653
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)240704
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 04/06/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/09/2026; 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic