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WATER CONTAINER (CONTAINER) MAJ-1026Recalls & reported problems

Olympus Medical Systems Corp. · GJ838400 MAJ-901 WATER BOTTLE REPAIR UN · Class 2

Data updated Oct 16, 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 04953170079238), received between Mar 15, 2022 and Mar 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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 16, 2026.

Most reported problems

Device problems

  • Contamination1

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.

  • MalfunctionMar 15, 2022Contamination; Contamination

    THE USER FACILITY REPORTED THAT DURING PRE-USE INSPECTION OF THE SUBJECT DEVICE WHICH HAD JUST BEEN DELIVERED, FOREIGN MATTER WAS FOUND IN THE TANK OF THE DEVICE. THE FOREIGN MATTER WAS THOUGHT TO POSSIBLY BE A PIECE OF PLASTIC DERIVED FROM THE PRODUCT. THERE WAS NO IMPACT ON THE INTENDED PROCEDURE, WHICH WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT/USER HARM OR INJURY DUE TO THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13766593 ↗

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Sources and updates

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