Olympus WA91500ARecalls & reported problems
OLYMPUS Winter & Ibe GmbH · Light source "EndoLED", for rigid endoscopes · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761070010), received between Mar 10, 2025 and Feb 26, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Battery 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Battery Problem1
- Failure to Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Battery Problem
IT WAS REPORTED THAT THE LIGHT SOURCE HAD INTERMITTENTLY WORKING NEW BATTERIES. THE ISSUE WAS IDENTIFIED UPON RECEIPT OR DURING UNPACKING OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457151 ↗MalfunctionMar 10, 2025Failure to Power Up; Failure to Power Up
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21567526 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.