ENDOLIGHT 5164001Recalls & reported problems
Richard Wolf GmbH · LIGHT SOURCE LED 2.2 80W LED, low operating noise level, dialog function, LED, buttons, compatible with core nova, universal light cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim (wxhxd) 300x160x424mm · Class 2
- 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 04055207055212), received between Jul 31, 2025 and Jul 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Burn(s)1
- 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.
MalfunctionJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE NURSE BURNED HER HAND WHILE HANDLING THE LIGHT CABLE OUTSIDE OF THE 2.2 LIGHT SOURCE DURING USE. THE OPERATION WAS COMPLETED WITHOUT HARM TO PATIENT AND WITHOUT DELAY.
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 22677436 ↗
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- Olympus WA91502AOLYMPUS Winter & Ibe GmbH · Led Light Source29 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.