Single use Surgical Optical Fiber EMP-FBX550HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033945938444), received between Apr 29, 2026 and Apr 29, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K180158); 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Overheating of Device

  A FLAME WAS OBSERVED ON THE LASER FIBER NEAR THE CONNECTION TO THE LASER MACHINE. THE FLAME WAS IMMEDIATELY CALLED OUT AND EXTINGUISHED WITH A WET TOWEL. NO HARM OR INJURY TO PATIENT WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25031045 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180158. One submission often covers many models, so check the product and lot details in each record.

• Z-1842-2021 · Apr 27, 2021 · Terminated
  Olympus Sterile Optical Laser Fiber, single use and reusable