Single use Surgical Optical Fiber EMP-FBX365HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033945938437), received between Jul 30, 2020 and Oct 29, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2020Therapeutic or Diagnostic Output Failure

  THE OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10756319 ↗
• MalfunctionOct 29, 2020Therapeutic or Diagnostic Output Failure

  THE OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10756298 ↗
• MalfunctionJul 30, 2020Therapeutic or Diagnostic Output Failure

  THE OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10344247 ↗

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