AIRSEAL AS-iFS1Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10851885004587), received between Oct 20, 2022 and Jul 20, 2026 — classified as 4 deaths, 36 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Loss of Power” (22 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 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE DEVICE, AS-IFS1, AIRSEAL IFS, 120V, WAS USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿SUBCUTANEOUS EMPHYSEMA OCCURRED.¿ THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF MALFUNCTION FOR ANY CONMED DEVICE. AN IAS12-100LPI, 12 MM ACCESS PORT & PALM GRIP OBT W/BLADELESS OPTICAL TIP AND AN ASM-EVAC1, TRI-LUMEN FILTERED TUBE SET WITH ACTIVATED CHARCOAL FILTER, WERE ALSO USED IN THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF PATIENT DEVELOPING SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Air Embolism

  MAUDE report 25870312 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1 AIRSEAL IFS, 120V DEVICE WAS BEING USED ON AN UNKNOWN DATE DURING A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS PROCEDURE WHEN IT WAS REPORTED ¿DR. AT (B)(6) HOSPITAL RECENTLY HAD 3 SURGERIES WITH AIRSEAL, USING AN 8MM PORT ON BARIATRIC PATIENTS WHO WERE UNDERGOING A COMBINATION OF A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS. HER PATIENTS EXPERIENCED VARYING LEVELS OF SUBCUTANEOUS EMPHYSEMA, WITH ONE PATIENT HAVING SUCH BAD EMPHYSEMA IN THEIR FACE THAT THEY WERE UNRECOGNIZABLE FOR DAYS.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THESE WERE HIGH BMI PATIENTS AND THE PORT WAS RESTING AGAINST PATIENT ANATOMY. THERE WAS NO INDICATION OF THE DEVICE MALFUNCTIONING DURING THIS EVENT. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS ¿RECOVERED¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT OBTAINING SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Air Embolism

  MAUDE report 25476692 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1 AIRSEAL IFS, 120V DEVICE WAS BEING USED ON AN UNKNOWN DATE DURING A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS PROCEDURE WHEN IT WAS REPORTED ¿DR. AT U OF R HIGHLAND HOSPITAL RECENTLY HAD 3 SURGERIES WITH AIRSEAL, USING AN 8MM PORT ON BARIATRIC PATIENTS WHO WERE UNDERGOING A COMBINATION OF A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS. HER PATIENTS EXPERIENCED VARYING LEVELS OF SUBCUTANEOUS EMPHYSEMA, WITH ONE PATIENT HAVING SUCH BAD EMPHYSEMA IN THEIR FACE THAT THEY WERE UNRECOGNIZABLE FOR DAYS.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THESE WERE HIGH BMI PATIENTS AND THE PORT WAS RESTING AGAINST PATIENT ANATOMY. THERE WAS NO INDICATION OF THE DEVICE MALFUNCTIONING DURING THIS EVENT. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS ¿RECOVERED¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT OBTAINING SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Air Embolism

  MAUDE report 25476657 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1 AIRSEAL IFS, 120V DEVICE WAS BEING USED ON AN UNKNOWN DATE DURING A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS PROCEDURE WHEN IT WAS REPORTED ¿DR. AT U OF R HIGHLAND HOSPITAL RECENTLY HAD 3 SURGERIES WITH AIRSEAL, USING AN 8MM PORT ON BARIATRIC PATIENTS WHO WERE UNDERGOING A COMBINATION OF A SLEEVE AND / OR BYPASS WITH HIATAL HERNIA REPAIRS. HER PATIENTS EXPERIENCED VARYING LEVELS OF SUBCUTANEOUS EMPHYSEMA, WITH ONE PATIENT HAVING SUCH BAD EMPHYSEMA IN THEIR FACE THAT THEY WERE UNRECOGNIZABLE FOR DAYS.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THESE WERE HIGH BMI PATIENTS AND THE PORT WAS RESTING AGAINST PATIENT ANATOMY. THERE WAS NO INDICATION OF THE DEVICE MALFUNCTIONING DURING THIS EVENT. THE PATIENT¿S CURRENT CONDITION WAS REPORTED AS ¿RECOVERED¿. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT OBTAINING SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Air Embolism

  MAUDE report 25476654 ↗
• MalfunctionMay 15, 2026Gas Output Problem; Output Problem

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MAUDE REPORT(B)(4) ON 05MAY26. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE AS-IFS1 AIRSEAL IFS, 120V DEVICE THAT WAS BEING USED DURING AN UNKNOWN PROCEDURE ON APPROXIMATELY (B)(6) 2026. THE REPORT STATED, ¿LOSS OF AIRSEAL SUDDENLY DURING PROCEDURE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO 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 25183717 ↗
• MalfunctionMay 7, 2026Loss of Power

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 120V DEVICE WAS USED IN AN UNNAMED PROCEDURE ON AN UNKNOWN DATE, AND ¿THE DEVICE SHUT DOWN DURING STARTUP.¿. ADDITIONAL INFORMATION INDICATED "REGARDING THE USE OF THE TERM ¿DURING STARTUP¿ IN THE INITIAL REPORT, THIS WAS DUE TO A MISTRANSLATION WHEN WE TRANSLATED THE ORIGINAL JAPANESE EXPRESSION ¿XXX¿ INTO ENGLISH. IN THIS CASE, ¿XXX¿ WAS INTENDED TO MEAN THAT THE DEVICE WAS OPERATING WHILE USING AIRSEAL, RATHER THAN THE INITIAL SYSTEM STARTUP PHASE." FURTHER ASSESSMENT FOUND THAT PNEUMOPERITONEUM HAD BEEN FULLY ESTABLISHED AND WAS LOST SUDDENLY WHEN THE DEVICE SHUT DOWN." 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25110134 ↗
• MalfunctionApr 28, 2026Power Problem

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 120V DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND ¿THE POWER WENT OUT DURING THE OPERATION, AND AFTERWARDS THERE WAS A BURNING SMELL. THE SURGERY WAS THEN CONTINUED AFTER REPLACING IT WITH ANOTHER AIR SEAL.¿. FURTHER ASSESSMENT FOUND ¿THE DEVICE WAS SHUT DOWN SUDDENLY, AND THERE WAS NO ALARM. THE PNEUMO WAS LOST¿ SUDDENLY. THE PROCEDURE WAS COMPLETED, WITH 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015453 ↗
• MalfunctionMar 24, 2026Unintended Deflation

  THIS COMPLAINT WAS CREATED BY THE FINDING OF MAUDE REPORT NUMBER (B)(4). THE ACCOUNT AND CONTACT INFORMATION FOR THIS REPORT ARE NOT KNOWN. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS WRITTEN AGAINST AN AS-IFS1, AIRSEAL IFS, 120V DEVICE, WHICH EXPERIENCED ¿LOSS OF AIRSEAL SUDDENLY DURING PROCEDURE¿. FURTHER ASSESSMENT FOUND: ¿PATIENT WAS NOT INJURED; NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION WAS REQUIRED FOR THE PATIENT; PATIENT WAS DISCHARGED FROM THE HOSPITAL SAME DAY WITH NO ILL EFFECTS. THE SURGICAL PROCEDURE BEING PERFORMED WAS A ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND LYMPH NODE DISSECTION; SURGICAL PROCEDURE WAS COMPLETED AS NORMAL; AN ALTERNATIVE DEVICE WAS NOT UTILIZED. THE DEVICE WAS POWERED OFF AND RESTARTED WHICH CLEARED THE PROBLEM. A SHORT DELAY OF 3-5 MINUTES WHILE POWERING OFF AND RESTARTING THE DEVICE WAS NOTED. THE PRESSURE LOSS EXPERIENCED WAS NOT DURING A CRITICAL TIME OF THE PROCEDURE HOWEVER THE PROVIDER REQUESTED DOCUMENTATION OF THE ISSUE AS IT HAS HAPPENED BEFORE. THERE WERE NO ALARMS OR WARNINGS PRIOR TO THE LOSS OF AIRSEAL. PN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674854 ↗
• InjuryMar 23, 2026Protective Measures Problem

  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

  Patient problems: Pneumothorax

  MAUDE report 24662292 ↗
• MalfunctionMar 23, 2026Complete Loss of Power

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 120V DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND ¿UNEXPECTED POWER SHUTDOWN¿ OCCURRED. FURTHER ASSESSMENT FOUND THAT PNEUMOPERITONEUM WAS SUDDENLY AND COMPLETELY LOST. THE PROCEDURE WAS COMPLETED AS NORMAL, WITH THE USE OF AN "ALTERNATIVE INSUFFLATION DEVICE". 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661028 ↗
• MalfunctionMar 10, 2026No Pressure

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556815 ↗
• MalfunctionMar 5, 2026Gas Output Problem

  THE CUSTOMER REPORTED THAT THE DEVICE, AS-IFS1, AIRSEAL IFS, 120V, WAS USED DURING A RARP PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿DURING THE PROCEDURE, THE GAS CYLINDER BECAME EMPTY AND THE VALVE COCK WAS TURNED TO SWITCH TO ANOTHER CYLINDER. HOWEVER, THE CYLINDER LEVEL DISPLAYED ON THE AIRSEAL MAIN UNIT DID NOT CHANGE, RESULTING IN LOSS OF INSUFFLATION. SINCE THE UNIT HAS BEEN IN USE FOR LESS THAN ONE YEAR SINCE DELIVERY, AN INSPECTION IS REQUESTED. AT THE TIME OF THE EVENT, INSTRUMENTS HAD ALREADY BEEN INSERTED, BUT THE SPECIFIC FORCEPS USED ARE UNKNOWN. THERE WAS NO IMPACT ON THE PATIENT, AND THE INSUFFLATION PAUSE LASTED APPROXIMATELY ONE AND A HALF MINUTES.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT A REPORTED DELAY. FURTHER ASSESSMENT FOUND THAT THERE WAS A COMPLETE LOSS OF PENUMO THAT HAPPENED RAPIDLY. ALL INSTRUMENTS WERE REMOVED FROM THE PATIENT WITHOUT PROBLEM. 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 24517934 ↗
• InjuryFeb 17, 2026Mechanical Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, AS-IFS1, AIRSEAL IFS, 120V, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿AIRSEAL DUMPED PRESSURE AFTER "VENTING VALVE ERROR" MESSAGE, RESULTING IN AN INSTRUMENT BURN OF THE AORTA.¿. FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER; HOWEVER, TO DATE, NO ANSWERS HAVE BEEN RECEIVED. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION OF THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF BURN TO AORTA DUE TO LOSS OF PRESSURE.

  Patient problems: Burn(s)

  MAUDE report 24363486 ↗
• InjuryFeb 11, 2026Insufficient Device Problem Information

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5180940) RECEIVED ON 14JAN23. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THEAS-IFS1, AIRSEAL IFS, 120V DEVICE. THE TYPE OF EVENT WAS REPORTED AS ¿SERIOUS INJURY¿. THE EVENT WAS DESCRIBED AS ¿INSUFFLATOR MALFUNCTIONED WHILE IN USE IN THE OPERATING ROOM¿, AND THE OUTCOME ATTRIBUTED TO THE EVENT WAS REPORTED AS ¿HOSPITALIZATION¿. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT IS BEING RAISED ON THE BASIS OF A PRESUMED INJURY, WHICH WAS NOT DEFINED BY THE REPORTER.

  Patient problems: Insufficient Information

  MAUDE report 24312478 ↗
• MalfunctionFeb 9, 2026Complete Loss of Power

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE AIRSEAL IFS, 120V DEVICE, WAS BEING USED DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿THE AIRSEAL SHUT DOWN TWICE.¿. FURTHER ASSESSMENT FOUND THAT THE PNEUMOPERITONEUM APPEARS TO HAVE BEEN RAPIDLY LOST. THE PATIENT WAS REPORTED TO HAVE NO INJURY AND THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS "UNKNOWN"." THERE WERE NO ALARMS OR NOTIFICATIONS DURING THIS EVENT. IT IS ALSO UNKNOWN IF INSTRUMENTS WERE INSERTED OR REMOVED FROM THE PATIENT DURING THIS EVENT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED 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 24290068 ↗
• DeathDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, AS-IFS1, AIRSEAL IFS, 120V, WAS BEING USED DURING A RIGHT THORACIC CASE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿EMBOLISM CAUSED A STROKE¿RESULTED IN A PATIENT DEATH.¿. FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER, AND IT WAS FOUND THAT THE SURGERY WAS 2 HOURS AND 26 MINUTES. BOTTLE GAS WAS USED, AND THE DEVICE PRESSURE WAS SET AT 5. NO HISTORY OF SICKLE CELL ANEMIA, AND THERE IS NO MENTION OF PULMONARY INSUFFICIENCY IN PATIENT'S EHR. NO ECHOCARDIOGRAM WAS PERFORMED DURING ADMISSION, AND THERE IS NOT A PREVIOUS ECHO AVAILABLE IN THE PATIENT'S EHR. PATIENT HAD LUNG CANCER AND HAD RECENTLY HAD CHEMOTHERAPY. THERE WAS NO REPORT OF MALFUNCTION FOR THE CONMED DEVICE. THIS REPORT IS BEING RAISED DUE TO ADVISEMENT OF PATIENT DEATH.

  Patient problems: Air Embolism; Stroke/CVA

  MAUDE report 23876001 ↗
• DeathDec 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, AS-IFS1, AIRSEAL IFS, 120V, WAS BEING USED DURING A RIGHT THORACIC CASE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿EMBOLISM CAUSED A STROKE¿ PATIENT IS CURRENTLY IN CRITICAL CONDITION.¿. CONMED WAS LATER ADVISED THAT THE PATIENT HAD PASSED AWAY. FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER, AND IT WAS FOUND THAT THE PROCEDURE WAS ABORTED DUE TO SURGEON VISUALIZING AIR WITHIN THE PULMONARY VEIN AND ARTERY AS WELL AS HEMODYNAMIC INSTABILITY. THE GAS SENSOR ALARM DID GO OFF, BUT THE STAFF IN THE ROOM CANNOT REMEMBER THE WORDS DISPLAYED IN THE ERROR MESSAGE. IT IS REPORTED THAT THE PRESSURE OF THE AIRSEAL INCREASED. PRESSURE WAS SET AT 5. BOTTLE GAS WAS USED. THE SURGERY WAS 1 HOUR AND 15 MINUTES. THE PATIENT HAD NO HISTORY OF SICKLE CELL ANEMIA, AND THERE IS NO MENTION OF PULMONARY INSUFFICIENCY IN PATIENT'S EHR. ECHOCARDIOGRAM PERFORMED DURING ADMISSION DID NOT IDENTIFY EVIDENCE OF A PFO. PATIENT HAD DIAGNOSIS OF LUNG CANCER AND HAD RECENTLY HAD CHEMOTHERAPY. THIS REPORT IS BEING RAISED DUE TO ADVISEMENT OF PATIENT DEATH.

  Patient problems: Air Embolism; Stroke/CVA

  MAUDE report 23875999 ↗
• MalfunctionDec 17, 2025Gas Output Problem; Gas Output Problem

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828588 ↗
• MalfunctionDec 15, 2025Gas Output Problem; Gas Output Problem

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AS-IFS1, AIRSEAL IFS, 120V WAS BEING USED DURING A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2025 AND ¿REPORTED OVERPRESSURE SPIKES OCCURRING ON THE GUI SCREEN OF THE IFS ONCE TUBESET WAS CONNECTED TO PORT. VISUALLY, THE ABDOMEN PRESSURE APPEARED NORMAL, EVENTUALLY PNEUMO WAS TOTALLY LOST.¿ PER FURTHER ASSESSMENT IT WAS REPORTED "THERE WAS AN ENDOSCOPE IN THE PATIENT, NO SHARPS. THE PNEUMO LOSS WAS SUDDEN AFTER 3+ SECONDS OF OVER PRESSURE READINGS." THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED AND THERE WAS A 5-MINUTE DELAY. PATIENT STATUS WAS REPORTED AS ¿OK¿. THE IAS5-120LP 5 MM ACCESS PORT & LOW-PROFILE OBTURATOR WILL BE LISTED AS A CONCOMITANT DEVICE. 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 23809927 ↗
• MalfunctionNov 24, 2025Loss of Power; Loss of Power

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629993 ↗
• MalfunctionNov 10, 2025Loss of Power; Loss of Power

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, AS-IFS1, AIRSEAL IFS, 120V, WAS BEING USED DURING A ROBOTIC PROSTATE PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿TURNING ON AND OFF DURING USE¿. FURTHER ASSESSMENT FOUND THIS OCCURRED DURING SURGERY. PNEUMO HAD BEEN ESTABLISHED AND THERE WAS A RAPID LOSS OF FULL PNEUMO. 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 23508987 ↗
• MalfunctionNov 10, 2025Loss of Power; Loss of Power

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, AS-IFS1, AIRSEAL IFS, 120V, WAS BEING USED DURING A CHOLECYSTECTOMY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿THIS UNIT FAILED IN A CASE. IT SHUT OFF COMPLETELY WITH AN ERROR SCREEN THAT SAID THERE WAS A VALVE ERROR,JUST CAME BACK FROM SERVICE A LITTLE OVER A MONTH AGO¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE SHUT OFF AND LOST FULL PNEUMO IMMEDIATELY. ALL INSTRUMENTS WERE REMOVED AFTER A STANDARD INSUFFLATOR WAS CONNECTED AND PNUEMO WAS RE-ESTABLISHED. 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 23508928 ↗
• MalfunctionNov 3, 2025Loss of Power; Loss of Power

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE AS-IFS1, AIRSEAL IFS, 120V WAS BEING USED AND ¿THE AIRSEAL UNIT SHUT DOWN.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT "THE POWER SUDDENLY WENT OUT AFTER THE PNEUMOPERITONEUM HAD BEEN ESTABLISHED, ABOUT 20 MINUTES BEFORE THE END OF THE OPERATION. IT SEEMS THAT THE PNEUMOPERITONEUM WAS LOST ALL AT ONCE." 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450560 ↗
• MalfunctionOct 29, 2025Defective Alarm; Unintended Deflation; Defective Alarm; Unintended Deflation

  A CUSTOMER REPORTED THAT THE AS-IFS1, AIRSEAL IFS, 120V DEVICE WAS USED IN A ROBOTIC HYSTERECTOMY BILATERAL SALPINGECTOMY VAULT SUSPENSION PROCEDURE ON AN UNREPORTED DATE, AND ¿THE UNIT FAILED DURING A SURGERY AND NEEDED TO BE INVESTIGATED. THERE WAS NO PATIENT INJURY. UNIT DEFLATED/RELEASED PRESSURE DURING SURGERY. MINOR DELAY NO SPECIFIC TIME REPORTED.¿. FURTHER ASSESSMENT FOUND THAT PNEUMOPERITONEUM WAS COMPLETELY LOST FOLLOWING A ¿LEAK ALARM/WARNING¿. "THERE WAS A SUDDEN LOSS OF PRESSURE PRECEDED BY AN AIRSEAL ALARM NOTIFYING OF A POSSIBLE LEAK. THE SURGICAL TEAM VERIFIED THAT ALL PORTS WERE CLOSED, CONTAINED, AND THERE WAS NO POSSIBLE SOURCE OF LEAK, AND SHORTLY AFTER THE MACHINE FULLY DESUFFLATED THE ABDOMEN. TEAM DID NOT HAVE TIME TO REMOVE INSTRUMENTS ONCE DESUFFLATION STARTED. ONCE AN ALTERNATIVE INSUFFLATOR WAS CONNECTED, THE TEAM VERIFIED THERE WAS NO INJURY TO BOWEL". THE PROCEDURE WAS COMPLETED WITH A "NON-AIRSEAL INSUFFLATOR DEVICE". THERE WAS NO 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413908 ↗
• InjurySep 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THE DEVICE, AS-IFS1, AIRSEAL IFS, 120V, WAS BEING USED DURING A ROBOT-ASSISTED UTERINE MALIGNANT TUMOR SURGERY PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿DURING THE INTERVIEW, WE LEARNED THAT IN THE FIVE MOST RECENT CASES OF UTERINE BODY CANCER IN WHICH PAN DISSECTION WAS PERFORMED USING A ROBOT, SUBCUTANEOUS EMPHYSEMA OCCURRED IN TWO CASES, MAKING EXTUBATION DIFFICULT.¿ A GOOD FAITH EFFORT WAS COMPLETED TO OBTAIN FURTHER INFORMATION; HOWEVER, TO DATE, CONMED HAS NOT RECEIVED A RESPONSE FROM THE REPORTER. THERE HAS NOT BEEN ANY ALLEGATION OF MALFUNCTION FOR THE CONMED DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF SUBCUTANEOUS EMPHYSEMA.

  Patient problems: Air Embolism

  MAUDE report 23178339 ↗