ENDOLIGHT 5165002Recalls & reported problems
Richard Wolf GmbH · LIGHT SOURCE LED GREEN For fluorescence imaging with ICG dye, With 2 LED light sources, Quiet operation, Dialog function, compatible with core nova, WOLF 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 04055207065631), received between Mar 2, 2023 and Mar 2, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Electrical /Electronic Property 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.
Most reported problems
Device problems
- Electrical /Electronic Property Problem1
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 2, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE USER FACILITY HAS REPORTED AN ISSUE REGARDING A LIGHT SOURCE LED GREEN, PART NO. 5165002, AND SERIAL NO. (B)(4). "INTRAOPERATIVELY SWITCH LAPAROSCOPY CAMERA TO ICG LIGHT. THIS CAUSES TECHNICAL DIFFICULTIES. THE ICG LIGHT SOURCE DOES NOT WORK. DESPITE NUMEROUS ATTEMPTS TO ELIMINATE THESE TECHNICAL DIFFICULTIES, INCLUDING CALLS TO THE REPRESENTATIVE OF WOLF-CORPORATION, IT IS NOT POSSIBLE TO CORRECT THE DEFECT." THE USER FACILITY HAS STATED THAT THE PATIENT WAS DOING WELL ALTHOUGH, SCHEDULED PROCEDURE WAS NOT COMPLETED. ADDITIONAL UNSCHEDULED MEDICAL TREATMENT NEEDS TO BE TAKEN TO COMPLETE THE PLANNED PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16470476 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.