Water container MAJ-901Recalls & reported problems
Olympus Medical Systems Corp. · "MAJ-901 WATER CONTAINER SET CV-160/140" · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170022913), received between Apr 25, 2023 and Sep 6, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Reprocessing Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Reprocessing Problem2
- Adverse Event Without Identified Device or Use Problem1
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.
MalfunctionSep 6, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE WATER CONTAINER WAS WASHED WITH WATER, AND THEN WASHED WITH DETERGENT AND DISINFECTED OR STERILIZED AT THE END OF EACH DAY. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20164632 ↗InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED DURING AN EMERGENCY DIAGNOSTIC ENDOSCOPY EXAMINATION AT NIGHT, A PATIENT WAS MISTAKENLY GIVEN A DETERGENT SOLUTION OR ALCOHOL TO THE WATER IN THE WATER CONTAINER. IT WAS ESTIMATED THE DETERGENT OR ALCOHOL WENT INTO THE DIGESTIVE TRACT. THE FACILITY STAFF REALIZED THAT IT HAD BEEN USED INCORRECTLY AFTER THE PROCEDURE WAS COMPLETED. THE DOCTORS BELIEVE THERE WOULD BE LITTLE HARM TO THE PATIENT BECAUSE IT WAS NOT A LARGE DOSE. THE PATIENT WAS UNDER OBSERVATION FOR A FEW DAYS AND THEN DISCHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18916553 ↗MalfunctionApr 25, 2023Device Reprocessing Problem; Device Reprocessing Problem
THE EVENT OCCURRED BEFORE AN UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. IT IS UNKNOWN IF THERE IS A DELAY IN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16809405 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page