AIRSEAL IAS8-120LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10845854045701), received between Sep 14, 2021 and Feb 3, 2026 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026

  12MM TROCAR AIRSEAL STATING OVERPRESSURE AND DOES NOT GO INTO AIRSEAL MODE. NEW AIRSEAL BOX BROUGHT IN AND NEW TROCAR OPENED STILL SHOWING SAME PROBLEM. SUSPECTING BAD BATCH FOR 12 AIRSEAL TROCARS, SAME LOT NUMBERS. SWITCHED TO AN 8 AIRSEAL TORCAR WHICH INITIALLY ALSO STATED OVERPRESSURE BUT SELF-ADJUSTED AND VENTED TO APPROPRIATE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246054 ↗
• MalfunctionNov 28, 2025Increase in Pressure

  DURING THE SURGERY, AN AIRSEAL IAS8-120LP WAS UTILIZED BUT IT WAS NOT REGULATING PROPERLY, OR IT WAS SAYING "OVERPRESSURE" AND NEEDING TO VENT PER SURGEON. IT WAS REMOVED FROM THE OPERATING ROOM AND EXCHANGED FOR A NEW DEVICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671593 ↗
• MalfunctionNov 24, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS8-120LP, 8 MM ACCESS PORT & LOW PROFILE OBTURATOR, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿CUSTOMER STATED THE SOUND CAP SEALS BROKE OFF DURING BOTH PROCEDURES WHEN INTRODUCING THE INSTRUMENT INTO THE PORT. NO PATIENT INJURY WAS REPORTED IN EITHER CASE AND THERE WAS NO DELAY. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUES.¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE DID FRAGMENT AND FALL INTO THE SURGICAL SITE. THE FRAGMENT WAS RETRIEVED, AND THE SURGERY WAS COMPLETED. 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 23629992 ↗
• MalfunctionNov 24, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS8-120LP, 8 MM ACCESS PORT & LOW PROFILE OBTURATOR, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿CUSTOMER STATED THE SOUND CAP SEALS BROKE OFF DURING BOTH PROCEDURES WHEN INTRODUCING THE INSTRUMENT INTO THE PORT. NO PATIENT INJURY WAS REPORTED IN EITHER CASE AND THERE WAS NO DELAY. PROCEDURES WERE COMPLETED SUCCESSFULLY WITH NO FURTHER ISSUES.¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE DID FRAGMENT AND FALL INTO THE SURGICAL SITE. THE FRAGMENT WAS RETRIEVED, AND THE SURGERY WAS COMPLETED. 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 23629990 ↗
• MalfunctionOct 10, 2025Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT MW5175447 ON 2OCT25. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST IAS8-120LP, 8 MM ACCESS PORT & LOW PROFILE OBTURATOR, DEVICE. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2025. THE REPORT STATED, "PLACED THE AIRSEAL IN THE PATIENT AND WAS WORKING FOR APPROXIMATELY 10 MINUTES WHEN THEY NOTICED THE RUBBER SEAL FROM THE TROCAR. DR. (B)(6) REMOVED THE RUBBER SEAL. THERE WAS NO PATIENT HARM AND TROCAR NEVER LOST PNEUMO SO CASE COULD PROCEED." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED AS PLANNED WITHOUT ANY DELAY. FURTHER ASSESSMENT CONFIRMED THAT THE FRAGMENT HAD FALLEN INTO THE PATIENT AND WAS RETRIEVED USING A GRASPER. THE PATIENT¿S CURRENT STATUS WAS REPORTED AS "FINE¿. 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 23265058 ↗
• MalfunctionJul 31, 2025Material Separation; Material Separation

  A CUSTOMER REPORTED THAT THE IAS8-120LP, 8 MM ACCESS PORT & LOW-PROFILE OBTURATOR DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2025, AND ¿IAS8-120LP POPPED OFF WHEN IN USE AND WENT IN TO PT ABDOMEN. HAD TO BE RETRIEVED FROM INSIDE THE PT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 22677572 ↗
• MalfunctionMar 21, 2025Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS8-120LP, 8 MM ACCESS PORT & LOW PROFILE OBTURATOR DEVICE WAS USED ON 21FEB25, AND ¿A UNKNOWN PIECE OF PLASTIC WAS FOUND IN THE PATIENTS THORACIC CAVITY DURING A ROBOTIC ASSISTED LEFT UPPER LOBECTOMY. AFTER PIECE WAS FOUND WE DID SOME EXPLORING ON THE FIELD TO SEE WHERE THIS CAME FROM. IT WAS DETERMINED THE PIECE CAME FROM THE FLAP OF THE CAP OF THE AIRSEAL DEVICE WHERE OTHER FLAPS WERE ALSO STARTING TO BREAK OFF. THE AIRSEAL WAS THEN REMOVED AND EXCHANGED FOR A DIFFERENT ONE.¿. FURTHER ASSESSMENT CONFIRMED THE FRAGMENT WAS REMOVED FROM THE PATIENT USING A "SURGICAL INSTRUMENT". THERE WAS "NO HARM" TO THE PATIENT, AND NO MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT OR USER. 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 21662172 ↗
• MalfunctionMar 18, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS8-120LP, 8 MM ACCESS PORT & LOW PROFILE OBTURATOR WAS BEING USED ON (B)(6) 2025 AND THE ¿TROCAR BROKE IN HALF DURING SURGERY¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT THE DEVICE DID FRAGMENT AND FALL INTO THE SURGICAL SITE. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THERE WAS NO IMPACT TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITH ¿A DIFFERENT AIRSEAL PORT¿. THERE WAS A DELAY OF ¿NO INSUFFLATION FOR 10 MINUTES OR SO¿. 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 21630032 ↗
• MalfunctionMar 10, 2025Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS8-120LP, 8 MM ACCESS PORT & LOW PROFILE OBTURATOR DEVICE WAS USED IN A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2025, AND ¿BLUE FOAM BECAME LOOSE DURING CASE. NO OTHER ISSUES OCCURRED. REPLACED THE SOUND CAP. NO PROBLEMS WITH CASE OR PATIENT. JUST WANTED TO REPORT SOUNDCAP DID NOT WORK PROPERLY¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND A DELAY OF ONE MINUTE. FURTHER ASSESSMENT FOUND "THE BLUE FOAM IN THE SOUND CAP DETACHED AND BECAME LOOSE, ALSO TWO OUT OF THE FOUR SLITS ON TOP DETACHED INTO THE SURGICAL SITE. THEY WERE QUICKLY AND EASILY RETRIEVED FROM THE SURGICAL SITE WITH A LAPAROSCOPIC GRASPER.". 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 21561726 ↗
• MalfunctionNov 26, 2024Material Fragmentation; Material Fragmentation

  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 IAS8-120LP, 8 MM ACCESS PORT & LOW-PROFILE OBTURATOR WAS BEING USED ON (B)(6)2024 AND ¿PART OF THE AIRSEAL ACCESS PORT BROKE OFF INSIDE OF PATIENT'S ABDOMEN DURING ROBOTIC, LAPAROSCOPIC PROCEDURE. THE PIECE WAS RETRIEVED; NO HARM NOTED TO PATIENT.". THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. THIS WAS REPORTED AS A DEVICE MALFUNCTION NOT AN ADVERSE EVENT. THE REPORTER REMAINED ANONYMOUS. 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 20785201 ↗
• MalfunctionOct 31, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT IAS8-120LP 8 MM ACCESS PORT & LOW-PROFILE OBTURATOR WAS BEING USED ON (B)(6) 2024 DURING A ROBOTIC ASSISTED LAP COLECTOMY PROCEDURE WHEN IT WAS REPORTED ¿PIECE OF AIRSEAL TROCAR BROKE AND WAS FOUND INSIDE THE PATIENT'S ABDOMEN" AND "UPDATE FOR THIS COMPLAINT. TALKED TO THE SURGEON AND IT WAS NOT A PLASTIC PIECE OF THE TROCAR ITSELF. IT WAS A RUBBER PIECE TO THE SOUND CAP THAT WAS FOUND IN THE ABDOMEN. HE BELIEVES IT MAY HAVE GOTTEN CAUGHT ON A GRASPER AND PULLED INTO THE ABDOMEN WHEN IT RIPPED.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS REMOVED WITH THE USE OF A ROBOTIC ARM. A 10-MINUTE DELAY WAS REPORTED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 20576868 ↗
• MalfunctionOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, IAS8-120LP, 8 MM ACCESS PORT & LOW-PROFILE OBTURATOR, WAS BEING USED ON (B)(6) 2024 DURING A ROBOTIC HYSTERECTOMY AND ¿AN AIRSEAL PORT THAT SEAL CAME OUT AND WENT IN THE PATIENT. THE STAFF NOTICED AND RETRIEVED THE PIECE." THERE WAS NO IMPACT OR INJURY FOR THE PATIENT. AN ALTERNATE DEVICE WAS NOT USED. 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 20343082 ↗
• MalfunctionMay 23, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE IAS8-120LP, AIRSEAL 8/120MM PORT, DEVICE WAS BEING USED DURING A ROBOTIC UROLOGY CASE PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED ¿PART OF CAP OF AIRSEAL PORT BROKE OFF AND ENDED UP IN PATIENT.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS REMOVED FROM THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE AIRSEAL PORT AND A 30-MINUTE DELAY. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿OKAY¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 19380314 ↗
• MalfunctionApr 8, 2024Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE IAS8-120LP, AIRSEAL 8/120MM PORT DEVICE WAS BEING USED DURING A ROBOTIC LOBECTOMY PROCEDURE ON 12MAR24, AND ¿THE RUBBER/PLASTIC FLANGES ON THE SOUND CAP AIRSEAL 8MM TROCAR BROKE OFF. [DR.] SAID THIS DUE TO HER ASSISTANT PUSHING THE ROLLED UP KITNERS (THEY CALL THEM CIGARS) AGGRESSIVELY THRU SOUND CAP¿. PER FOLLOW-UP ASSESSMENT, "THE SURGEON SAID THERE WERE NO FRAGMENTS RETAINED INSIDE THE PATIENT, AND THE PATIENT WAS FINE. SHE WAS CONFIDENT THAT ALL FRAGMENTS WERE ACCOUNTED FOR, AND HAD HER ASSISTANT PLACE ALL OF THEM ON THE BACK TABLE WITH THE SOUND CAP AND REST OF 8 MM TROCAR AND OBTURATOR". THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND WITH A DELAY OF 30 SECONDS. 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 19061434 ↗
• MalfunctionNov 6, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, IAS8-120LP, AIRSEAL 8/120MM PORT, WAS BEING USED DURING A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6)2023 WHEN IT WAS REPORTED, ¿AIRSEAL 8-PLASTIC PRONG BROKE OFF AND WENT INTO PATIENT, NO HARM TO PATIENT.¿. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FOUND FROM THE REPORTER, ¿THE PIECE THAT FELL OFF WAS THE INTERNAL PLASTIC PIECE THAT STRIATED THAT INSTRUMENT PASSES THROUGH. THE PIECE COMPLETELY FELL INTO THE PATIENT. IT WAS RETRIEVED AND WAS ALL IN ONE PIECE.¿ THERE WAS NO REPORT OF PROCEDURE DELAY. 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 18072237 ↗
• MalfunctionMay 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS8-120LP, AIRSEAL 8/120MM PORT WAS BEING USED ON (B)(6) 2023 DURING A VENTRAL HERNIA PROCEDURE AND ¿I HAD AN INCIDENT WHERE THE VALVE ON THE AIRSEAL SOUND CAP HAD COME OUT AND WAS INSIDE THE PATIENT¿S ABDOMEN. THE PHYSICIAN¿S ASSISTANT BELIEVES IT CAME OUT WHILE THEY WERE PASSING MESH FOR A VENTRAL HERNIA. THEY WERE ABLE TO REMOVE IT AND THE PATIENT WAS FINE, BUT STATED IF THEY HAD NOT SEEN IT, THEY COULD HAVE LEFT IT IN THE PATIENT.¿. THERE WAS NO INJURY OR IMPACT TO THE PATIENT OR USER. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE CAP WAS REMOVED WITH A SURGICAL GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY. ¿PATIENT IS FINE.¿ THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED FOR THE PATIENT/USER. 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 16843173 ↗
• MalfunctionMar 27, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER IAS8-120LP, AIRSEAL 8/120MM PORT WAS BEING USED DURING A HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿A DEFECTIVE AIRSEAL PORT WHERE A PIECE OF THE SOUND CAP FELL INTO THE PATIENT.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND WAS RETRIEVED USING "ROBOT ARM AND GRASPER.¿ THE PROCEDURE WAS COMPLETED WITH A REPORTED ¿SMALL DELAY TO RETRIEVE THE PIECE.¿ THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿PATIENT IS FINE.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION REQUIRED 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 16620394 ↗
• InjuryDec 28, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS8-120LP, AIRSEAL 8/120MM PORT, WAS USED DURING A GYN PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿AIRSEAL 8 MM TROCAR SOUND CAP FLAPS BROKE OFF AND FELL IN THE PATIENT. THE SURGEON WAS UNABLE TO RETRIEVE ALL OF THE FLAPS AND 3 OF THE 4 FLAPS WERE LEFT IN THE PATIENT.¿. THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATIVE DEVICE AND THERE WAS NO REPORT OF A DELAY TO THE CASE. FURTHER ASSESSMENT QUESTIONING FOUND THAT NO IMAGING WAS DONE TO HELP LOCATE THE 3 MISSING DEVICE CAPS AND THE PATIENTS STATUS WAS, ¿OKAY¿. THIS WAS REPORTED FOR A LIFE THREATENING INJURY, BUT THERE WAS NO REPORT OF MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO FRAGMENTATION LEFT IN THE BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16062952 ↗
• MalfunctionOct 19, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE IAS8-120LP, AIRSEAL 8/120MM PORT, WAS BEING USED DURING A HYSTERECTOMY PROCEDURE ON (B)(6)2022 WHEN IT WAS REPORTED, THIS AFTERNOON A PIECE OF THE 8MM AIRSEAL SOUND CAP CAME APART AND FELL INTO PATIENT. THE PIECE WAS REMOVED, PATIENT IS FINE. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH A 3 MINUTE DELAY. THE FRAGMENTATION WAS REMOVED FROM THE PATIENT USING ROBOTIC GRASPERS. THE PATIENT¿S STATUS WAS LISTED AS FINE, HEALTHY, NO ISSUES. 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 15630893 ↗
• MalfunctionOct 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS8-100LP, AIRSEAL 8/100MM PORT WAS BEING USED ON (B)(6)2022 AND A PIECE OF RUBBER FELL OFF THE ACCESS PORT INTO THE PATIENT, THEY WERE ABLE TO RETRIEVE IT. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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 15562864 ↗
• MalfunctionApr 25, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS8-120LP, AIRSEAL 8/120MM PORT WAS BEING USED ON (B)(6) 2022 DURING AN UNKNOWN PROCEDURE AND ¿HAD A PIECE COME OFF OF AN ACCESS PORT DURING THE PROCEDURE. THE PATIENT WAS NOT HARMED AS THE FIRST ASSIST CAUGHT IT RIGHT AWAY.¿ THE PROCEDURE WAS COMPLETED WITH A 3-5 MINUTE DELAY. THERE NO INJURY TO THE PATIENT OR USER REPORTED. THERE WAS ALSO NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THIS EVENT. FURTHER ASSESSMENT HAS BEEN SENT; HOWEVER, TO DATE NO REPLY HAS BEEN RECEIVED. 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 14196446 ↗
• InjuryNov 16, 2021Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, IAS8-120LP, AIRSEAL 8/120MM PORT, WAS BEING USED ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE AND THE 8 MM SOUND CAP FLAP BROKE OFF AND FELL IN TO PATIENT ABDOMEN WHILE NURSE WAS PASSING SUTURE THROUGH IT. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. FURTHER ASSESSMENT QUESTIONS HAVE BEEN SENT, BUT TO DATE NO RESPONSE HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO POSSIBLE RETAINED FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12819083 ↗
• MalfunctionSep 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED ISSUES WITH THE IAS8-120LP, AIRSEAL 8/120MM PORT, LOT 202106024, THAT DR. (B)(6)OF (B)(6) GENERAL HEALTH/ WOMEN¿S AND BABIES HOSPITAL RECENTLY EXPERIENCED ON (B)(6) 2021 (PATIENT (B)(6)). INFORMATION RECEIVED INDICATES ¿INNER SEAL OF TROCAR SEPARATED FROM TROCAR WHEN INSTRUMENT REMOVED FROM PATIENT'S ABDOMEN. NO RETAINED MATERIAL IN PATIENT. TROCAR ASSESSED, ALL PIECES INTACT. ¿ THERE IS NO INDICATION OF IMPACT OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE AS THE PORT PIECE FELL INTO THE PATIENT BUT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467024 ↗