Smith & Nephew Insufflator 500 72203994Recalls & reported problems
Northgate Technologies Inc. · Insufflator, Laparoscopic, 50LPM · Class 2
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 00817183020677), received between Jul 21, 2021 and Jul 21, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Increase in Pressure” (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.
Most reported problems
Device problems
- Increase in Pressure1
Patient problems
- Cardiovascular Dysfunction/Insufficiency1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2021Increase in Pressure; Increase in Pressure
ON 6/22/2021 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT WITH A SMITH & NEPHEW INSUFFLATOR, " IT WAS REPORTED THAT DURING A SURGERY THE INSUFFLATOR PRESSURE REQUESTED WAS 15MM HG BUT THE FLOW BECAME FREE AND ROSE TO 19MM HG AND WAS INCREASING, THE INSUFFLATOR WAS TURNED OFF BY THE NURSE. THE PATIENT HAD A HEART ATTACK DURING THE PROCEDURE. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED." NO FURTHER INFORMATION HAS BEEN RECEIVED BY THE MANUFACTURER DESPITE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION.
Patient problems: Cardiovascular Dysfunction/Insufficiency
MAUDE report 12207811 ↗
Other Insufflator, Laparoscopic devices
- HIGH FLOW INSUFFLATION UNIT UHI-3Olympus Medical Systems Corp. · INSUFFLATOR, LAPAROSCOPIC1 recall162 reports
- 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
- Pneumosure 0620040680Stryker Corporation · 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 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.
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