MAUDE Adverse Event Report: CONMED AIRSEAL; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS2
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.The service history was reviewed and no relationship to this complaint was found.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of 71 complaints, regarding 71 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (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.
Event or Problem Description
The sales representative reported on behalf of the customer that the airseal ifs, 230v device was being used during a robot-assisted laparoscopic prostatectomy procedure on (b)(6) 2026 when it was reported ¿during the operation, after approximately one hour of surgery, the airseal unit suddenly shut down without warning and restarted itself.It was running in airseal mode at the time.After the restart, the unit functioned normally.No alarms were triggered during the shutdown or the restart.¿ further assessment found that ¿during the start-up phase of the procedure, a sudden loss of pneumoperitoneum occurred without any prior warning.This happened shortly after the airseal mode had been activated, with all robotic instruments already docked.The pressure dropped immediately, and the staff did not have time to remove any instruments before the loss of pressure occurred.¿.The procedure was completed with a 5-minute delay.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: AIRSEAL
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): W O M WORLD OF MEDICINE GMBH; salzufer 8; berlin 10587 ; GM 10587
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 24429233
• Report Number: 1320894-2026-00039
• Device Sequence Number: 18740241
• Product Code: HIF
• UDI-Device Identifier: 10851885004594
• UDI-Public: (01)10851885004594(11)200618
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K230239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• 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