NA 242391Recalls & reported problems
Medos International Sàrl · LIGHT GUIDE, OLYMPUS - ACMI 3.5MM X 4.0M · Class 2
Data updated Oct 16, 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 10886705028849), received between Feb 15, 2022 and Feb 15, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionFeb 15, 2022Break; Break
IT WAS REPORTED BY SALES REP THAT THE LIGHT CORD WAS BROKEN ON THE FUSLITEGU_OLYM-ACMI_3.5MMX4.0M DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13536821 ↗
Other LIGHT, SURGICAL, FIBEROPTIC devices
- NA 242386Medos International Sàrl · LIGHT, SURGICAL, FIBEROPTIC49 reports
- Arthrex® AR-3240-5027Arthrex, Inc. · LIGHT, SURGICAL, FIBEROPTIC30 reports
- Integra® 001388LX9Integra Lifesciences (Ireland) Limited · LIGHT, SURGICAL, FIBEROPTIC7 reports
- N/A FC1SPStryker Corporation · Light, Surgical, Fiberoptic5 reports
- UltraLite® AX2100BIFIntegra Lifesciences (Ireland) Limited · LIGHT, SURGICAL, FIBEROPTIC4 reports
- NA 242387Medos International Sàrl · LIGHT, SURGICAL, FIBEROPTIC3 reports
- Arthrex® AR-3240-5040Arthrex, Inc. · LIGHT, SURGICAL, FIBEROPTIC3 reports
- LITe DECOMPRESSION 48089999Stryker Corporation · LIGHT, SURGICAL, FIBEROPTIC2 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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