Single use Surgical Optical Fiber OAF002011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033945933487), received between Jul 8, 2019 and Feb 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (1 report).

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 22, 2023Protective Measures Problem

  MALFUNCTIONED WHILE TESTING-- DID NOT REACH PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416472 ↗
• MalfunctionJul 8, 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 8767123 ↗