NA 0233050084Recalls & reported problems
Stryker Corporation · Fiber Optic Light Cable, Opaque · Class 2
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 07613327051629), received between Nov 4, 2024 and Nov 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K082813); they may or may not involve this specific model.
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
- Output 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.
MalfunctionNov 4, 2024Output Problem; Output Problem
IT WAS REPORTED THAT THERE WAS LOSS OF LIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20602037 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K082813. One submission often covers many models, so check the product and lot details in each record.
- Z-1474-2023 · Mar 2, 2023 · Open, ClassifiedSafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Other Light source, fiberoptic, routine devices
- Integra® 00MLXIntegra Lifesciences (Ireland) Limited · Light source, fiberoptic, routine189 reports
- L9000 0220210000Stryker Corporation · Light source, fiberoptic, routine99 reports
- SafeLight 0233050100Stryker Corporation · Light source, fiberoptic, routine1 recall22 reports
- SafeLight 0233050087Stryker Corporation · Light source, fiberoptic, routine59 reports
- SafeLight 0233050200Stryker Corporation · Light source, fiberoptic, routine1 recall3 reports
- IRIS 0220180518Stryker Corporation · Light source, fiberoptic, routine43 reports
- n.a. 495NDKarl Storz GmbH & Co. KG · Light source, fiberoptic, routine23 reports
- PRECISION 0220220000Stryker Corporation · Light source, fiberoptic, routine22 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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