ENDO STRATUS CO2 Insufflator EGA-501Recalls & reported problems
Medivators Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00677964063671), received between Nov 29, 2016 and Jul 14, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Abdominal Pain1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT THE YOKE DUAL VALVE FOR THEIR CO2 TANK THAT ATTACHES TO THEIR ENDOSTATUS CO2 INSUFFLATOR WAS NOT OPERATING PROPERLY RESULTING IN PROCEDURE DELAYS. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17325840 ↗Nov 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FACILITY REPORTS THAT PATIENTS ARE EXPERIENCING POST PROCEDURE ABDOMINAL PAIN AND PRESSURE AFTER USING CO2 INSUFFLATOR.
Patient problems: Abdominal Pain
MAUDE report 6133860 ↗
Other Insufflator, Automatic Carbon-Dioxide For Endoscope devices
- HIGH FLOW INSUFFLATION UNIT UHI-4Olympus Medical Systems Corp. · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE3 recalls6 deaths2,484 reports
- ENDOFLATOR UI500Karl Storz GmbH & Co. KG · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE193 reports
- HIGH FLOW INSUFFLATION UNIT UHI-4Olympus Medical Systems Corp. · Insufflator, Automatic Carbon-Dioxide For Endoscope1 recall9 reports
- ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCROlympus Medical Systems Corp. · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE52 reports
- ENDOFLATOR UI400Karl Storz GmbH & Co. KG · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE40 reports
- ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCROlympus Medical Systems Corp. · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE16 reports
- CO2MPACT 710300US Endoscopy · INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE4 reports
- ENDOSCOPIC CO2 REGULATION UNIT OLYMPUS UCROlympus Medical Systems Corp. · Insufflator, Automatic Carbon-Dioxide For Endoscope2 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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