CO2EFFICIENT 710302Recalls & reported problems
US Endoscopy · The CO2EFFICIENT Endoscopic Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope. · Class 2
- 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 10816765013097), received between Jun 8, 2022 and Jun 8, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (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
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2022Obstruction of Flow; Obstruction of Flow
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE FLOW RATE ON THEIR COEFFICIENT ENDOSCOPIC INSUFFLATOR SYSTEM WAS LOW. A PROCEDURE DELAY WAS REPORTED DUE TO THE LOW FLOW RATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14631778 ↗
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
- ENDO STRATUS CO2 Insufflator EGA-501Medivators Inc. · Insufflator, Automatic Carbon-Dioxide For Endoscope2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.