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

Catalog Number	AS-IFS1
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the complaint investigation has not been completed.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.
Event or Problem Description
A sales representative reported on behalf of a customer that the as-ifs1, airseal ifs, 120v device was used in a robotic hysterectomy procedure on 17feb26, and airseal keeps switching in and out of airseal mode and lost pneumo because it was switching in and out - will be sending in for service¿.Further assessment found no device alarms were noted and pneumoperitoneum was completely lost, but it is unknown whether the loss was gradual or sudden.The "scrub tech reported pneumo was lost with a needle inside the patient however reported no patient injury", and "switched from airseal mode to standard insufflation mode to complete the procedure.Nothing was left inside the patient; they were able to retrieve the needle.".There was no report of 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.
Event or Problem Description
A sales representative reported on behalf of a customer that the as-ifs1, airseal ifs, 120v device was used in a robotic hysterectomy procedure on (b)(6) 2026, and airseal keeps switching in and out of airseal mode and lost pneumo because it was switching in and out - will be sending in for service".Further assessment found no device alarms were noted and pneumoperitoneum was completely lost, but it is unknown whether the loss was gradual or sudden.The "scrub tech reported pneumo was lost with a needle inside the patient however reported no patient injury", and "switched from airseal mode to standard insufflation mode to complete the procedure.Nothing was left inside the patient; they were able to retrieve the needle." there was no report of 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
Additional problems were found: venting valve error was found.The blocking valve was replaced, the vev on lpu was cleaned.The unit was calibrated, and electrical safety, then placed on 12-hour burn-in.The unit was tested in accordance with ip-800-031 and passed all acceptance criteria.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be a damaged valve.The service history was reviewed and found similar repairs to this complaint.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.(b)(4).Per the instructions for use, the user is advised that < 5 bar/73 psi; if insufflation is started, the warning message "change gas bottle!¿ is displayed and acoustic signals (beeps) are emitted.The gas bottle should be changed immediately.If insufflation is stopped, the warning message "change gas bottle!" is displayed and insufflation cannot be restarted.Smoke evacuation level will switch to low until tank is replaced.While in airseal mode, a countdown of 100 s is displayed during which the empty gas bottle can be changed while maintaining abdominal pressure 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 24556815
• Report Number: 1320894-2026-00045
• Device Sequence Number: 18524525
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)181130
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic