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

Catalog Number	IAS12-100LPI
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Conmed japan reported on behalf of the customer that the ias12-100lpi 12 mm access port & palm grip obt w/bladeless optical tip, was being used during a robot-assisted gastric procedure on (b)(6) 2026 when it was reported, ¿the blue portion of the sound reduction cap caught on forceps and was damaged, and a fragment fell into the abdominal cavity; however, it was successfully retrieved.¿.The procedure was completed with the use of an alternate device.And there was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: AIRSEAL
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED; 525 french raod; utica NY 13502
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 25534267
• Report Number: 3007305485-2026-00130
• Device Sequence Number: 21250242
• Product Code: GCJ
• UDI-Device Identifier: 10845854045640
• UDI-Public: (01)10845854045640(17)280519(10)202505204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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
• Device Catalogue Number: IAS12-100LPI
• Device Lot Number: 202505204
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• 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: 07/22/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown