BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSEAL

    MDR report key: 23828588 · Received December 17, 2025

    Report

    Report Number
    1320894-2025-00285
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    December 5, 2025
    Report Date
    January 21, 2026
    Manufacturer
    CONMED
    Product Code
    HIF
    UDI-DI
    10851885004587
    PMA / PMN Number
    K190303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247811 AIRSEAL INSUFFLATOR, LAPAROSCOPIC HIF CONMED 10851885004587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown