Single use Surgical Optical Fiber EMP-FBX200HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08033945938413), received between Jun 25, 2019 and Nov 18, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2021Break; Fracture; Break; Fracture

  OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW ITS USE ANYMORE. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834265 ↗
• MalfunctionNov 4, 2021Fracture; Fracture

  BROKEN OPTICAL FIBER. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750381 ↗
• MalfunctionNov 26, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 10911297 ↗
• MalfunctionSep 18, 2020Defective Component; Detachment of Device or Device Component; Detachment of Device or Device Component

  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 10552518 ↗
• MalfunctionAug 7, 2020Fracture; Therapeutic or Diagnostic Output Failure; Fracture

  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; No Known Impact Or Consequence To Patient

  MAUDE report 10377573 ↗
• MalfunctionJul 17, 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 10288391 ↗
• MalfunctionMay 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component; Therapeutic 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; No Known Impact Or Consequence To Patient

  MAUDE report 10101065 ↗
• MalfunctionOct 29, 2019Therapeutic 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 9248712 ↗
• MalfunctionSep 17, 2019Therapeutic or Diagnostic Output Failure

  AN OPTICAL FIBERS 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 9075877 ↗
• MalfunctionJun 25, 2019Therapeutic 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 8731024 ↗

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