n.a. 8587GFRecalls & reported problems
Karl Storz GmbH & Co. KG · Fiber Optic Light Carrier, 7.5 cm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551211274), received between Jun 21, 2019 and Jun 21, 2019 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Overheating of Device1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 21, 2019Overheating of Device
ALLEGEDLY, DURING A PROCEDURE THE FIBER OPTIC LIGHT CARRIER BECAME HOT, IT OVER HEATED, AND BURNED THE PATIENT'S TONGUE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8725057 ↗
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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