MAUDE Adverse Event Report: CONMED AIRSEAL; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS1
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.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
The customer reported that the device, as-ifs1, airseal ifs, 120v, was being used during a robot assisted rectal resection procedure on (b)(6) 2025 when it was reported, ¿the device suddenly restarted during surgery.After the restart, the surgery continued without any problems.The circumstances at the time of the incident were as follows, when the power went out, the pneumoperitoneum was rapidly lost, the forceps were not inserted into the trocar when the pneumoperitoneum was lost before the roll-in, there was no particular health risk to the patient, the power cord was connected to a single outlet, without using multiple power strips.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported to have been completed as planned.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: d3 updated with legal mfg.D4 updated with serial number.Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.The service history was reviewed, and no data was found.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 customer reported that the device, as-ifs1, airseal ifs, 120v, was being used during a robot assisted rectal resection procedure on (b)(6) 2025 when it was reported, ¿the device suddenly restarted during surgery.After the restart, the surgery continued without any problems.The circumstances at the time of the incident were as follows, when the power went out, the pneumoperitoneum was rapidly lost, the forceps were not inserted into the trocar when the pneumoperitoneum was lost before the roll-in, there was no particular health risk to the patient, the power cord was connected to a single outlet, without using multiple power strips.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported to have been completed as planned.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.; 4th floor; utica NY 13502
• Manufacturer (Section G): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; 4th floor; berlin 10587 ; GM 10587
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23629993
• Report Number: 1320894-2025-00265
• Device Sequence Number: 10380799
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)191209
• 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,Followup
• Report Date (Section B): 12/17/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2019
• 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