NA 72204922Recalls & reported problems
Smith & Nephew, Inc. · UNIVERSAL LIGHT GUIDE ORANGE 4MM X 12 FT · Class 2
Data updated Oct 16, 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 00885556643716), received between Aug 8, 2018 and May 20, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Thermal Decomposition of Device2
- Image Display Error/Artifact1
- Material Discolored1
- Material Integrity Problem1
- Peeled/Delaminated1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2025Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SKIN OF ONE (1) UNIVERSAL LIGHT GUIDE WAS PEELING OFF. THE PROCEDURE WAS PERFORMED, AFTER A DELAY GREATER THAN 30 MINUTES, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22057091 ↗MalfunctionAug 8, 2018Thermal Decomposition of Device; Material Discolored
IT WAS REPORTED THAT DUE TO FIBER DAMAGE AND UNEXPLAINABLE BURNING OF THE UNIVERSAL LIGHT GUIDE, THE SCREEN COLORED YELLOW. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7763584 ↗MalfunctionAug 8, 2018Thermal Decomposition of Device; Image Display Error/Artifact; Material Integrity Problem
IT WAS REPORTED THAT DUE TO FIBER DAMAGE AND UNEXPLAINABLE BURNING OF THE UNIVERSAL LIGHT GUIDE, THE SCREEN COLORED YELLOW. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7763581 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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