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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

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Sources and updates

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