NA 7209944Recalls & reported problems
Smith & Nephew, Inc. · GAS WARMER IN-LINE S&N · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010500601), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Thermal Decomposition of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 28, 2019Thermal Decomposition of Device; Thermal Decomposition of Device
ON 05/30/2019, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ISSUE WITH AN IN-LINE WARMER FROM DISTRIBUTOR (B)(4) IN THE USA WHERE IT WAS ALLEGED, "IT WAS REPORTED THAT THE DEVICE STARTED HEATING UP AND THE CABLE STARTED SMOKING, THEN THE CONTROL UNIT TURNED OFF. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED. BACK UP DEVICE WAS AVAILABLE."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8744812 ↗
Other INSUFFLATOR, LAPAROSCOPIC devices
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- HIGH FLOW INSUFFLATION UNIT UHI-3Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC1 recall48 reports
- AIRSEAL AS-iFS1Conmed Corporation · Insufflator, laparoscopic4 deaths93 reports
- Pneumosure 0620040610Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 death79 reports
- Pneumosure 0620040690Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall22 reports
- Pneumosure 0620040660Stryker Corporation · INSUFFLATOR, LAPAROSCOPIC1 recall18 reports
- CYLINDER HOSE (PIN) FOR UHI-3 MAJ-1080Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC58 reports
- STORZ 20400161SCanadian Hospital Specialties Limited · Insufflator, Laparoscopic1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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