Single use Surgical Optical Fiber EMP-FBX200BHSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08033945938468), received between Aug 1, 2019 and Jun 4, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2021Fracture; 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

  MAUDE report 11942527 ↗
• MalfunctionMar 9, 2021Detachment 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 11445048 ↗
• MalfunctionDec 16, 2020Output Problem

  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 11019876 ↗
• MalfunctionDec 3, 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 10942289 ↗
• MalfunctionJun 30, 2020Appropriate Device Problem Term/Code Not Available; Therapeutic or Diagnostic Output Failure; 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; No Known Impact Or Consequence To Patient

  MAUDE report 10211357 ↗
• MalfunctionJan 17, 2020Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem

  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 9600935 ↗
• MalfunctionAug 1, 2019Output Problem

  TWO OPTICAL FIBERS HAD A FAILURE THAT DID NOT ALLOW TO USE THEM PROPERLY. THEY WERE USED WITH EMPOWER 35 LASER (SERIAL NUMBER: (B)(4)). NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8850491 ↗

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