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	11/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgery, an airseal ias8-120lp was utilized but it was not regulating properly, or it was saying "overpressure" and needing to vent per surgeon.It was removed from the operating room and exchanged for a new device.No patient harm.

• Brand Name: AIRSEAL
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french rd; utica NY 13502
• MDR Report Key: 23671593
• Report Number: 23671593
• Device Sequence Number: 9761910
• Product Code: GCJ
• UDI-Device Identifier: 10845854045701
• UDI-Public: (01)10845854045701(17)280325(10)202503264
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/14/2025
• Report Date (Section F): 11/14/2025

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: 202503264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2025
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Date Report Sent to FDA: 11/14/2025