MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	IAS8-120LP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
12mm trocar airseal stating overpressure and does not go into airseal mode.New airseal box brought in and new trocar opened still showing same problem.Suspecting bad batch for 12 airseal trocars, same lot numbers.Switched to an 8 airseal torcar which initially also stated overpressure but self-adjusted and vented to appropriate pressure.

• Brand Name: AIRSEAL
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 24246054
• Report Number: 24246054
• Device Sequence Number: 21247162
• Product Code: GCJ
• UDI-Device Identifier: 10845854045701
• UDI-Public: (01)10845854045701(17)281031(10)202511014
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2026
• Report Date (Section F): 01/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IAS8-120LP
• Device Catalogue Number: IAS8-120LP
• Device Lot Number: 202511014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Date Report Sent to FDA: 01/21/2026