AIRSEAL AS-IFS2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10851885004594), received between Nov 2, 2023 and May 1, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Loss of Power” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Loss of Power

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE AS-IFS2, AIRSEAL IFS, 230V DEVICE WAS USED IN A ROBOTIC SURGERY WITH THE DA VINCI XI SURGICAL SYSTEM GASTRECTOMY ON (B)(6) 2026, AND ¿SUDDENLY DURING THE PROCEDURE, WITHOUT ANY SPECIFIC ACTION OR CHANGE IN USAGE, THE AIRSEAL UNIT SHUT DOWN. WHEN ATTEMPTING TO RESTART, THE DISPLAY SHOWED THE ERROR MESSAGE: ¿ELECTRONIC ERROR! RESTART THE DEVICE AND CONTACT SERVICE.¿ THE UNIT WAS RESTARTED, BUT THE SAME ERROR MESSAGE REAPPEARED. THE DEVICE WAS RESTARTED AGAIN WITH THE SAME RESULT. A DIFFERENT AIRSEAL UNIT WAS THEN BROUGHT IN AND CONNECTED USING THE SAME TUBING SET AND PORT. THE REPLACEMENT UNIT FUNCTIONED NORMALLY, AND THE PROCEDURE COULD CONTINUE AS PLANNED. THE AIRSEAL SYSTEM WAS USED IN AIRSEAL MODE WITH AN AIRSEAL TUBING SET AND PORT.¿ FURTHER ASSESSMENT FOUND, "THE GAS LOSS MUST HAVE OCCURRED SUDDENLY. AT THE SAME TIME, IT IS ALWAYS DIFFICULT TO ASSESS EXACTLY HOW THE PROCESS OCCURRED IN RETROSPECT, BUT IN THAT CASE, THEY DID NOT HAVE TIME TO REMOVE THE INSTRUMENTS. HOWEVER, THERE WAS NOT ANY DAMAGE DONE." THE PROCEDURE WAS COMPLETED WITH A DELAY OF 5 MINUTES. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION, OR E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058148 ↗
• MalfunctionFeb 24, 2026Unexpected Shutdown

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AIRSEAL IFS, 230V DEVICE WAS BEING USED DURING A ROBOT-ASSISTED LAPAROSCOPIC PROSTATECTOMY PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED ¿DURING THE OPERATION, AFTER APPROXIMATELY ONE HOUR OF SURGERY, THE AIRSEAL UNIT SUDDENLY SHUT DOWN WITHOUT WARNING AND RESTARTED ITSELF. IT WAS RUNNING IN AIRSEAL MODE AT THE TIME. AFTER THE RESTART, THE UNIT FUNCTIONED NORMALLY. NO ALARMS WERE TRIGGERED DURING THE SHUTDOWN OR THE RESTART.¿ FURTHER ASSESSMENT FOUND THAT ¿DURING THE START-UP PHASE OF THE PROCEDURE, A SUDDEN LOSS OF PNEUMOPERITONEUM OCCURRED WITHOUT ANY PRIOR WARNING. THIS HAPPENED SHORTLY AFTER THE AIRSEAL MODE HAD BEEN ACTIVATED, WITH ALL ROBOTIC INSTRUMENTS ALREADY DOCKED. THE PRESSURE DROPPED IMMEDIATELY, AND THE STAFF DID NOT HAVE TIME TO REMOVE ANY INSTRUMENTS BEFORE THE LOSS OF PRESSURE OCCURRED.¿. THE PROCEDURE WAS COMPLETED WITH A 5-MINUTE DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429233 ↗
• MalfunctionSep 20, 2024Pressure Problem; Pressure Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS2, AIRSEAL IFS, 230V WAS BEING USED ON 2SEP24 AND ¿THE SEQUENCE OF EVENTS HAS HAPPENED WITH BOTH ROBOTIC SOLUTION AND STANDARD AIRSEAL PORTS. WHAT HAS HAPPENED IS THAT THEY HAVE STARTED THE OPERATION AS USUAL, CONNECTED THE LUER TUBE AND GOT GAS INTO THE ABDOMEN AND THEN STARTED AIRSEAL MODE, THEN DOCKED THE ROBOT AND STARTED THE OPERATION. IN THE MIDDLE OF THE OPERATION, THE ABDOMEN COLLAPSES, BUT THE AIRSEAL CONTINUES TO SHOW THE SET PRESSURE OF 8 MMHG. THEY START OVER WITH THE LUER HOSE, RESTART THE AIRSEAL AND SO ON AIRSEAL MODE BUT THE SAME PROBLEM PERSISTS, TRY CHANGING THE HOSE SET, THE PROBLEM PERSISTS. RESTARTING THE AIRSEAL TWICE BUT THE SAME PROBLEM AGAIN. THEY HAVE ALSO CHECKED THAT THE PORTS ARE INSIDE THE ABDOMEN AND CHECKED THAT THE TUBES ARE NOT PINCHED. THUS AN INTERMITTENT ERROR.¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT "THE FIRST TIME THIS PROBLEM OCCURRED THERE WAS A GRADUAL LOSS OF PNEUMOPERITONEUM SO THEY HAD TIME TO REMOVE THE INSTRUMENTS. AT THE SECOND AND THIRD TIME THERE WASN´T TIME TO NEITHER REMOVE THE CAMERA OR THE INSTRUMENTS WHICH CAUSED A STRESSFUL ENVIRONMENT AND PROLONGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20270352 ↗
• MalfunctionJun 7, 2024Loss of Power; Loss of Power

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, AS-IFS2, AIRSEAL IFS, 230V, WAS BEING USED DURING A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿AIRSEAL SYSTEM SHUT DOWN WITHOUT PRE WARNING DURING ROBOTIC GYN PROCEDURE. THE CUSTOMER WAS NOT ABLE TO RESTART THIS SYSTEM. THEY HAD TO TAKE IN A GENERIC INSUFFLATOR TO FINISH THE CASE. THERE WAS NO INJURY TO THE PATIENT. THE NEXT DAY THE SYSTEM WORKED NORMALLY DURING THE CASES.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THERE WAS A RAPID LOSS OF PNEUMO. THE INSTRUMENTATION WAS REMOVED SAFELY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A GENERIC INSUFFLATOR CAUSING A 15-20-MINUTE DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED AS ¿DOING FINE¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485160 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE AS-IFS2, AIRSEAL IFS, 230V WAS BEING USED DURING A LAPAROSCOPIC ONCOLOGIC PROCEDURE ON (B)(6) 2023, WHEN IT WAS REPORTED ¿DURING VERESS NEEDLE INSUFFLATION THE PATIENT GOT A VENTRICULAR FIBRILLATION AND CARDIAC ARREST, REANIMATION WAS NECESSARY. THE HEARD ULTRASOUND SHOW AIR IN THE HEART VENTRICLES. PROCEDURE WAS INTERRUPTED.¿ IT WAS ALSO REPORTED ¿PROCEDURE WAS INTERRUPTED AND PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE. THE PATIENT WILL BE MANAGED IN INTENSIVE CARE.¿ AN ALTERNATE DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE PATIENT OBTAINING VENTRICULAR FIBRILLATION AND CARDIAC ARREST LEADING TO TREATMENT IN THE INTENSIVE CARE UNIT.

  Patient problems: Cardiac Arrest

  MAUDE report 18057036 ↗