MAUDE Adverse Event Report: CONMED AIRSEAL; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	AS-IFS1
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales representative reported on behalf of the customer that the as-ifs1 device was used in a procedure on (b)(6) 2026; this information was clarified and updated with the receipt of medwatch report "mw5183061, received from the fda on 27feb26, which reported: ¿patient is 41-year-old female who was seen for robotic-assisted total laparoscopic hysterectomy, bilateral salpingectomy, sentinel node biopsy with possible bilateral oophorectomy due to precursor testing bordering on endometrial cancer.Procedure began with left upper quadrant entry approach (typical approach) with abdominal insufflation to 15mmhg (max).Airseal gave ¿overpressure warning¿ so tubing was swapped out at recommendation of circulator; error persisted, so surgeon requested to swap airseal machine after second set of tubing gave the same error.There were no errors with the second machine and patient was stable, so the procedure continued as planned.Approximately 10 minutes into the case, anesthesia had problems with the patient's oxygen saturation so physician docked the robot and aborted the procedure when the patient could not be stabilized.The patient does have a known history of asthma; taking this into consideration, anesthesia had attempted to stabilize sats with inhalation treatments and bronch prior to the procedure being aborted.The patient was taken to post-anesthesia care unit where chest x-ray showed a tension pneumothorax.Chest tube was placed in post-anesthesia care unit and disclosure was made to patient/family at time of procedure.Patient was taken back to or approximately 1.5 days later and was able to successfully have procedure completed laparoscopically without robotic assistance.Patient tolerated treatment well and was able to be discharged the following day.¿.The asm-evac1, tri-lumen filtered tube set with activated charcoal filter will be listed as a concomitant device, with no reportable allegations against it.This report is being raised due to the reported injury of a tension pneumothorax.
Additional Manufacturer Narrative
Additional problems were found.The preventative maintenance was overdue.Venting valve error was found.The compressor was refurbished.The unit was cleaned, lubricated, and calibrated.The performance safety test was completed and unit placed in 12 hours burn-in.The final test met specifications.The service history was reviewed and found similar repairs to this complaint.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 19 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 the use of carbon dioxide (co2) for insufflation at elevated intra-abdominal pressures has been associated with an increased risk of pneumothorax.This reisk may be heightened in procedures involving diaphragmatic manipulation, pre-existing pulmonary compromise, or prolonged insufflation time.To mitigate this risk, use the lowest clinically effective insufflation pressure necessary to maintain adequate operative visualization, continuously monitor patient respiratory status and end-tidal co2 levels during insufflation, and be prepared to initiate prompt clinical intervention should signs of pneumothorax occur (e.G., sudden desaturation, hemodynamic instability, increased airway pressures).We will continue to monitor per regulatory requirements to help ensure patient safety.

• 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: 24662292
• Report Number: 1320894-2026-00068
• Device Sequence Number: 9344500
• Product Code: HIF
• UDI-Device Identifier: 10851885004587
• UDI-Public: (01)10851885004587(11)190221
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Risk Manager
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AS-IFS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASM-EVAC1, TRI-LUMEN FILTERED TUBE SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic