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

Catalog Number	IAS5-120LP
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The customer reported that the device ias5-120lp, 5 mm access port & low-profile obturator was being used on (b)(6) 2026 during a hysterectomy and the ¿cannula broke midway up to the shaft outer lumen cracked with small 2x8 piece missing.Missing piece could not be located.X-ray taken without identification of piece in patient abdomen.¿ per further assessment it was reported "we cannot confirm whether or not the fragment of the cannula was retained or not retained within the patient.A kub intraoperative x-ray was taken in an attempt to locate the fragment.However, confidence was low for seeing the fragment on radiography due to the lack of or limited radiopacity of the material and small size of the fragment.The piece could possibly have been retained." there was no impact or injury to the patient or user.The procedure was completed with an alternate unknown device.There was a 60 to 90-minute delay to the procedure.This report is being raised due to the reported injury of patient could possibly have retained a device fragment.

• Brand Name: AIRSEAL
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED; 525 french rd.; utica NY 13502
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 25316322
• Report Number: 3007305485-2026-00117
• Device Sequence Number: 14747851
• Product Code: GCJ
• UDI-Device Identifier: 10845854045657
• UDI-Public: (01)10845854045657(17)290107(10)202601084
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: IAS5-120LP
• Device Lot Number: 202601084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown