MAUDE Adverse Event Report: CONMED AIRSEAL; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS1
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 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 (b)(4) reports, regarding (b)(4) 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 when working in the airseal mode, it is possible that fluids can be extracted from the surgical field over the evacuation line and into the filter housing.In order to prevent contamination of the device, bodily fluid is retained by the fluid trap of the housing component.The capacity of the fluid trap is limited.A warning message and an audible signal will be emitted if the fill level low is reached.Airseal cannula and tubing placement should be checked to make sure no more fluid enters the fluid trap.At this point, insert airseal obturator and change the filtered tube set.Insufflation can be continued with full functionality.If fluid level high is reached, the airseal function will shut down.Insert obturator in airseal cannula to maintain pressure with normal insufflation.Change the tube set to finish the procedure.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
Conmed japan reported on behalf of a customer that the as-ifs1, airseal ifs, 120v device was used in an unknown procedure on an unknown date, and ¿unexpected power shutdown¿ occurred.Further assessment found that pneumoperitoneum was suddenly and completely lost.The procedure was completed as normal, with the use of an "alternative insufflation device".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.

• 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: 24661028
• Report Number: 1320894-2026-00067
• Device Sequence Number: 9344454
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)170928
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2017
• 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