Single use Surgical Optical Fiber OFH302711Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033945937973), received between Mar 8, 2019 and Feb 13, 2025 — classified as 2 malfunctions.

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

• MalfunctionFeb 13, 2025Break; Output Problem; Break; Output Problem

  DURING SURGERY, THE DEVICE BROKE OFF INSIDE THE PATIENT. THE INITIAL CLINICAL PROCEDURE (LITHOTRIPSY) WAS COMPLETED TO THE BEST OF THE DOCTOR'S ABILITY. UPON REALIZING THE FIBER HAD BROKEN, THE DOCTOR ATTEMPTED TO RETRIEVE IT BUT WAS UNSUCCESSFUL, DECIDING TO LEAVE THE ITEM IN PLACE. THE PATIENT RETURNED FOUR WEEKS LATER FOR SURGERY TO REMOVE THE FRAGMENT. THERE WERE NO FURTHER CLINICAL REPERCUSSIONS FOR THE PATIENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21372676 ↗
• MalfunctionMar 8, 2019Therapeutic or Diagnostic Output Failure

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8402789 ↗

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