MAUDE Adverse Event Report: CONMED AIRSEAL; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS1
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
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.H3 other text : device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the as-ifs1, airseal ifs, 120v was being used on approximately (b)(6) 2025 and ¿¿basically the abdominal wall seems to collapse/his space collapses and doesn¿t look like the pneumo is working right.Occasionally it¿ll say trochar occluded but that¿s because the wall is sagging down.Pushing it in more doesn¿t always help.And sometimes it just resolves on its own.So, i¿m not sure but he wants it serviced." per further assessment it was reported that "this incident occurred after pneumoperitoneum was established.Dr.Xxx operates at a pressure of 6, meaning any loss of pneumo happens very fast.There was no injury to the patient, but robotic instruments were not removed as the pneumo space collapsed rapidly." there was no impact or injury to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of ¿loss of pneumo¿ was unconfirmed.The bezel was damaged and cracked.The unit was cleaned, lubricated, calibrated, the performance safety was tested, and placed in 12 hours burn-in.The unit was tested per ip-800-031.The unit functions as per the specification.The service history was reviewed, and no prior data 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 107 reports, regarding 107 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 the following: < 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 as-ifs1, airseal ifs, 120v was being used on approximately (b)(6) 2025 and ¿basically the abdominal wall seems to collapse/his space collapses and doesn¿t look like the pneumo is working right.Occasionally it¿ll say trochar occluded but that¿s because the wall is sagging down.Pushing it in more doesn¿t always help.And sometimes it just resolves on its own.So, i¿m not sure but he wants it serviced." per further assessment it was reported that "this incident occurred after pneumoperitoneum was established.Dr.(b)(6) operates at a pressure of 6, meaning any loss of pneumo happens very fast.There was no injury to the patient, but robotic instruments were not removed as the pneumo space collapsed rapidly." there was no impact or injury to the patient.This report is being raised due to 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, 4th floor; berlin 10587 ; GM 10587
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23828588
• Report Number: 1320894-2025-00285
• Device Sequence Number: 18458620
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)240923
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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