N/A 1882040HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20885074079794), received between Sep 28, 2020 and Jun 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 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.

• MalfunctionJun 1, 2021Vibration; Vibration

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT DURING INFERIOR TURBINATE REDUCTION, THE BLADE WOBBLED. THE PROCEDURE WAS COMPLETED BY A BACK UP PRODUCT WITH 10 MINUTES OF DELAY. THE DEVICE HAD CONTACT WITH THE PATIENT. THERE WAS NO PATIENT IMPACT. UPON FOLLOW UP IT WAS REPORTED THAT THE VIBRATING DEVICE WAS USED ON THE PATIENT. THE DELAY WAS SHORT AND HAD NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913959 ↗
• MalfunctionSep 28, 2020Material Fragmentation; Material Fragmentation

  A HEALTH CARE PROVIDER REPORTED THAT THE TIP BLADE BROKE OFF IN THE NOSE OF THE PATIENT. THE BROKEN PIECE WAS RETRIEVED SO THERE WAS NO HARM ON THE PATIENT. IT WAS THE FIRST TIME THE PRODUCT WAS USED. THE EVENT WAS DURING FUNCTIONAL ENDOSCOPICSINUS SURGERY, BILATERAL INFERIOR TURBINATE REDUCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596859 ↗