MAUDE Adverse Event Report: CONMED AIRSEAL; HIF - INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS1
Medical Device Problem Codes	Gas Output Problem (1266); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint was created due to the receipt of a maude report(b)(4) on 05may26.The report was found to be written against the as-ifs1 airseal ifs, 120v device that was being used during an unknown procedure on approximately (b)(6) 2026.The report stated, ¿loss of airseal suddenly during procedure.¿.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported 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: HIF - INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8, 4th floor; berlin 10587 ; GM 10587
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 25183717
• Report Number: 1320894-2026-00131
• Device Sequence Number: 18804823
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)230906
• Combination Product (Y/N): N
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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-IFS1
• 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: 05/27/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/08/2026
• Date Device Manufactured: 09/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Unknown