SafeLight 0233050490Recalls & reported problems
Stryker Corporation · Fiber Optic Light Cable with Advanced Imaging Modality, Right Angle · Class 2
All models of SafeLight (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 07613327462760), received between Mar 5, 2025 and Mar 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (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
- Overheating of Device1
- Temperature Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2025Overheating of Device; Temperature Problem; Overheating of Device; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: Insufficient Information
MAUDE report 21529700 ↗
Other Confocal optical imaging devices
- HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EAOlympus Medical Systems Corp. · Confocal Optical Imaging1,110 reports
- VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200Olympus Medical Systems Corp. · Confocal Optical Imaging870 reports
- HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EBOlympus Medical Systems Corp. · Confocal Optical Imaging698 reports
- L11 0220230300Stryker Corporation · Confocal optical imaging233 reports
- L10 0220220300Stryker Corporation · Confocal optical imaging77 reports
- AIM SafeLight 0233050300Stryker Corporation · Confocal optical imaging62 reports
- SafeLight 0233050400Stryker Corporation · Confocal optical imaging56 reports
- 1588 AIM 1588010000Stryker Corporation · Confocal optical imaging35 reports
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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