BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSEAL

    MDR report key: 24556815 · Received March 10, 2026

    Report

    Report Number
    1320894-2026-00045
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 17, 2026
    Report Date
    April 1, 2026
    Manufacturer
    CONMED
    Product Code
    HIF
    UDI-DI
    10851885004587
    PMA / PMN Number
    K190303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PROBLEMS WERE FOUND: VENTING VALVE ERROR WAS FOUND. THE BLOCKING VALVE WAS REPLACED, THE VEV ON LPU WAS CLEANED. THE UNIT WAS CALIBRATED, AND ELECTRICAL SAFETY, THEN PLACED ON 12-HOUR BURN-IN. THE UNIT WAS TESTED IN ACCORDANCE WITH IP-800-031 AND 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 A DAMAGED VALVE. 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. (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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 120V DEVICE WAS USED IN A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2026, AND AIRSEAL KEEPS SWITCHING IN AND OUT OF AIRSEAL MODE AND LOST PNEUMO BECAUSE IT WAS SWITCHING IN AND OUT - WILL BE SENDING IN FOR SERVICE". FURTHER ASSESSMENT FOUND NO DEVICE ALARMS WERE NOTED AND PNEUMOPERITONEUM WAS COMPLETELY LOST, BUT IT IS UNKNOWN WHETHER THE LOSS WAS GRADUAL OR SUDDEN. THE "SCRUB TECH REPORTED PNEUMO WAS LOST WITH A NEEDLE INSIDE THE PATIENT HOWEVER REPORTED NO PATIENT INJURY", AND "SWITCHED FROM AIRSEAL MODE TO STANDARD INSUFFLATION MODE TO COMPLETE THE PROCEDURE. NOTHING WAS LEFT INSIDE THE PATIENT; THEY WERE ABLE TO RETRIEVE THE NEEDLE." 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.

    Description of Event or Problem · 0

    A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 120V DEVICE WAS USED IN A ROBOTIC HYSTERECTOMY PROCEDURE ON 17FEB26, AND AIRSEAL KEEPS SWITCHING IN AND OUT OF AIRSEAL MODE AND LOST PNEUMO BECAUSE IT WAS SWITCHING IN AND OUT - WILL BE SENDING IN FOR SERVICE¿. FURTHER ASSESSMENT FOUND NO DEVICE ALARMS WERE NOTED AND PNEUMOPERITONEUM WAS COMPLETELY LOST, BUT IT IS UNKNOWN WHETHER THE LOSS WAS GRADUAL OR SUDDEN. THE "SCRUB TECH REPORTED PNEUMO WAS LOST WITH A NEEDLE INSIDE THE PATIENT HOWEVER REPORTED NO PATIENT INJURY", AND "SWITCHED FROM AIRSEAL MODE TO STANDARD INSUFFLATION MODE TO COMPLETE THE PROCEDURE. NOTHING WAS LEFT INSIDE THE PATIENT; THEY WERE ABLE TO RETRIEVE THE NEEDLE.". 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309995 AIRSEAL HIF - INSUFFLATOR, LAPAROSCOPIC HIF CONMED 10851885004587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown