MAUDE Adverse Event Report: CONMED AIRSEAL; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G3 initial awareness date was (b)(6) 2026.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 customer reported that the device, as-ifs1, airseal ifs, 120v, was used during an unknown procedure on an unknown date when it was reported, ¿subcutaneous emphysema occurred.¿ there was no report of medical intervention or hospitalization.The procedure was completed as planned without the use of an alternate device.There was no report of malfunction for any conmed device.An ias12-100lpi, 12 mm access port & palm grip obt w/bladeless optical tip and an asm-evac1, tri-lumen filtered tube set with activated charcoal filter, were also used in the procedure.This report is being raised due to the reported injury of patient developing subcutaneous emphysema.

• 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 ; 525 french rd.; utica, NY 13502 ; +1(727)399-5358
• MDR Report Key: 25870312
• Report Number: 1320894-2026-00181
• Device Sequence Number: 10642964
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)230927
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown