GAS/WATER VALVE MAJ-2010Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170437830), received between Dec 16, 2022 and Aug 27, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Corroded” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Corroded2
- Microbial Contamination of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2024Corroded; Corroded
IT WAS OBSERVED DURING THE DEVICE INSPECTION THE GAS/WATER VALVE¿S METAL PARTS WERE CORRODED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20082241 ↗MalfunctionAug 26, 2024Corroded; Corroded
IT WAS OBSERVED DURING THE DEVICE INSPECTION, GAS/WATER VALVE METAL PARTS CORRODED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20068135 ↗MalfunctionDec 16, 2022Microbial Contamination of Device; Microbial Contamination of Device
THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS LUCERA ELITE COLONOVIDEOSCOPE TESTED POSITIVE FOR MICROBIAL CONTAMINATION. THE SCOPE WAS SAMPLED TWICE. DURING THE FIRST SAMPLING, THE SCOPE TESTED POSITIVE FOR UNSPECIFIED COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA. DURING THE SECOND SAMPLING, THE SCOPE TESTED POSITIVE FOR UNSPECIFIED CFUS OF PSEUDOMONAS AERUGINOSA. THE ISSUE WAS FOUND AT REPROCESSING DURING A ROUTINE CULTURE OF THE SCOPE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15993731 ↗
Other Colonoscope And Accessories, Flexible/Rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 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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