Elevate™ ENT Elite Fiber 322001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00894338002825), received between Jul 26, 2019 and Jul 26, 2019 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K070157); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2019Mechanical Problem; Mechanical Problem

  REPORTEDLY A SMALL CRACK WAS FOUND IN THE LASER FIBER DURING THE PROCEDURE. THE FIBER WAS DISCONNECTED FROM THE LASER AND ANOTHER FIBER UTILIZED. THE PROCEDURE WAS THEN COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830887 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070157. One submission often covers many models, so check the product and lot details in each record.

• Z-0453-2013 · Nov 5, 2012 · Terminated
  OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body