Single use Surgical Optical Fiber EMP-FBX272HS-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08033945938529), received between Oct 29, 2019 and Apr 21, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (4 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.

• MalfunctionApr 21, 2025Fracture; Material Separation

  DURING CYSTOSCOPY/URETEROSCOPY AND HOLMIUM LASE, OPTIC FIBER FRACTURED WHILE INSIDE PATIENT. PATIENT HAD MULTIPLE LARGE STONES. ALL PIECES OF THE FIBER WERE REMOVED FROM THE PATIENT, NO INJURY NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874420 ↗
• MalfunctionApr 21, 2022Fracture; Fracture

  OPTICAL FIBER BROKE CAUSING A BLISTER TO THE OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166134 ↗
• MalfunctionApr 20, 2021Mechanical Problem; Mechanical Problem

  FIBER BOKE DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691800 ↗
• MalfunctionFeb 21, 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 9738520 ↗
• MalfunctionOct 29, 2019Therapeutic or Diagnostic Output Failure; Appropriate 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; No Known Impact Or Consequence To Patient

  MAUDE report 9248767 ↗
• MalfunctionOct 29, 2019Therapeutic or Diagnostic Output Failure; Appropriate 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; No Known Impact Or Consequence To Patient

  MAUDE report 9248765 ↗
• 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 9248758 ↗

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