Slimline EZ 365 FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290109140179), received between Nov 1, 2022 and Nov 14, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING PREPARATION OF THE PROCEDURE, THE SLIMLINE FIBER DID NOT WORK THE FIRST TIME IT WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FRACTURED CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683544 ↗
• MalfunctionJun 20, 2023Overheating of Device; Power Problem; Overheating of Device; Power Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE INDICATOR LIGHT GRADUALLY GREW DIMMER, INDICATING A DECLINE IN ENERGY OUTPUT. OVER TIME, THE CRUSHING ABILITY OF THE DEVICE DIMINISHED, AND EVENTUALLY, ALL ENERGY CEASED TO FLOW. UPON INSPECTING THE FIBER CONNECTOR, THE CORE OF THE FIBER WAS FOUND BURNED. AS A RESULT, THE PROCEDURE COULD NOT BE SUCCESSFULLY COMPLETED AND PATIENT WAS UNDER GENERAL ANESTHESIA. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164386 ↗
• MalfunctionNov 1, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FIBER BROKE AFTER 2 MINUTES OF FIRING DURING THE FIRST USE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712545 ↗