MAUDE Adverse Event Report: CONMED AIRSEAL; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint was created due to the receipt of a medwatch report (mw5180940) received on 14jan23.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against theas-ifs1, airseal ifs, 120v device.The type of event was reported as ¿serious injury¿.The event was described as ¿insufflator malfunctioned while in use in the operating room¿, and the outcome attributed to the event was reported as ¿hospitalization¿.Further assessment was attempted, and a good faith effort was made to obtain additional information; however, no response has been received to date.This report is being raised on the basis of a presumed injury, which was not defined by the reporter.
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.
Additional Manufacturer Narrative
The preventative maintenance was not overdue.The evaluation found contamination.Pressure leaked due to corrosion of the valve unit and a worn compressor.The repair was completed, the unit was calibrated, electrical safety tested and started on a 12-hr.Burn-in test.The unit passed 12-hour stress test.The unit was tested in accordance with (b)(4) and it 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 worn parts.The service history was reviewed and found similar problem 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 to not use device and/or accessories if signs of contamination are detected.Make sure the device or/and accessories can no longer be operated until a qualified service technician conducts the appropriate tests and repairs.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report (mw5180940) received on 14jan23.A search of the complaint system has not found a complaint reported for this device/lot number during this timeframe.The report was found to be written against theas-ifs1, airseal ifs, 120v device.The type of event was reported as ¿serious injury¿.The event was described as ¿insufflator malfunctioned while in use in the operating room¿, and the outcome attributed to the event was reported as ¿hospitalization¿.Further assessment was attempted, and a good faith effort was made to obtain additional information; however, no response has been received to date.This report is being raised on the basis of a presumed injury, which was not defined by the reporter.

• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 24312478
• Report Number: 1320894-2026-00031
• Device Sequence Number: 20043079
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)211117
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 01/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic