EXTRA LOW FLOW GAS TUBE MAJ-1816Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 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 04953170262562), received between Jul 18, 2023 and Jul 18, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Clean Adequately” (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
- Failure to Clean Adequately1
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.
MalfunctionJul 18, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS, DURING REPROCESSING, THE EXTRA LOW FLOW GAS TUBE HAD BLACK FOREIGN SUBSTANCE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17344615 ↗
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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