AIRSEAL IASB12-100Recalls & reported problems
Conmed Corporation · AIRSEAL 12 MM ACCESS PORT AND OBTURATOR WITH BLUNT TIP, 100 MM LENGTH · Class 2
All models of AIRSEAL (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854045602), received between Jul 17, 2025 and Jul 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2025Material Fragmentation; Material Fragmentation
A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE IASB12-100, 12 MM ACCESS PORT AND OBTURATOR WITH BLUNT TIP,100 MM LENGTH DEVICE WAS USED IN A PROCEDURE ON (B)(6) 2025, AND ¿IASB12-100 WAS BEING UTILIZED IN A ROBOTIC SURGERY WITH DAVINCI PORT ¿DOUBLE CANNULATED¿ INSIDE OF IT. STAFF NOTICED PORT WAS CRACKED AT THE DISTAL END OF HASSAN PORT, AND BLUE PLASTIC PIECE WAS SHATTERED AS WELL. PIECES OF PORT BROKE OFF INTO THE PATIENT. ACCORDING TO STAFF XRAY WAS DONE TO FIND PIECES THAT FELL INTO PATIENT, BUT STAFF WAS UNCERTAIN WHETHER THEY RETRIEVED ALL PIECES OUT OF THE PATIENT. WHEN SPEAKING TO DR. [¿] ON (6) 2025 WHO WAS NOT THE OPERATING SURGEON BUT WAS PRESENT IN THE ROOM, HE SAID HE DIDN¿T NOTICE ANYTHING OUT OF THE ORDINARY. OTHER STAFF WHO WERE PRESENT WERE NOT AROUND TO GIVE THEIR ACCOUNT, SO I WILL FOLLOW UP WITH MORE INFORMATION AS IT BECOMES AVAILABLE TO ME.¿. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF POSSIBLE RETAINED FOREIGN BODIES IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22529418 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page