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

Model Number	IAS12-120LPI
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Four rolled raytec sponges inserted through port by assisting pa for surgeons use with robotic arms inside patient.Surgeon noted blue triangular piece of silicone inside patient.

• Brand Name: AIRSEAL
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 18323517
• Report Number: 18323517
• Device Sequence Number: 7250559
• Product Code: GCJ
• UDI-Device Identifier: 10845854045688
• UDI-Public: (01)10845854045688(17)260504(10)202305055
• 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): 07/31/2023
• Report Date (Section F): 07/31/2023

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: Other
• Device Model Number: IAS12-120LPI
• Device Catalogue Number: IAS12-120LPI
• Device Lot Number: 202305055
• 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: 12/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2023
• 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 Sex: Male
• Patient Weight: 105 KG
• Date Report Sent to FDA: 07/31/2023