Adapter for UHI-2/3 MAJ-1873Recalls & reported problems
Olympus Medical Systems Corp. · Class U
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 04953170308475), received between Jun 22, 2022 and Sep 10, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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.
Reports received per month
Most reported problems
Device problems
- Display or Visual Feedback Problem1
- Failure to Power Up1
- Gas/Air Leak1
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 10, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THE HIGH FLOW INSUFFLATION UNIT HAD A GAS LEAK OCCURRED. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20181042 ↗MalfunctionOct 20, 2023Failure to Power Up; Failure to Power Up
THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT SWITCH ON. THE REPORTED ISSUE WAS OBSERVED WHILE PREPARING THE SUBJECT DEVICE, PRIOR TO AN UNSPECIFIED PROCEDURE. THERE WAS NO REPORT OF PATIENT OR USER INJURY DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17976516 ↗MalfunctionJun 22, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THE DISPLAY DOES NOT LIGHT UP. THE ISSUE FOUND DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14767494 ↗
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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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