MAUDE Adverse Event Report: CONMED AIRSEAL; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS2
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of a customer that the as-ifs2, airseal ifs, 230v device was used in a robotic surgery with the da vinci xi surgical system gastrectomy on (b)(6) 2026, and ¿suddenly during the procedure, without any specific action or change in usage, the airseal unit shut down.When attempting to restart, the display showed the error message: ¿electronic error! restart the device and contact service.¿ the unit was restarted, but the same error message reappeared.The device was restarted again with the same result.A different airseal unit was then brought in and connected using the same tubing set and port.The replacement unit functioned normally, and the procedure could continue as planned.The airseal system was used in airseal mode with an airseal tubing set and port.¿ further assessment found, "the gas loss must have occurred suddenly.At the same time, it is always difficult to assess exactly how the process occurred in retrospect, but in that case, they did not have time to remove the instruments.However, there was not any damage done." the procedure was completed with a delay of 5 minutes.There was no injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: AIRSEAL
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED; 525 french rd; utica 13502
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8, 4th floor; berlin 10587 ; GM 10587
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 25058148
• Report Number: 1320894-2026-00113
• Device Sequence Number: 18491602
• Product Code: HIF
• UDI-Device Identifier: 10851885004594
• UDI-Public: (01)10851885004594(11)210118
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

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 Catalogue Number: AS-IFS2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown