N/A 1882940Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20681490863364), received between Jan 3, 2017 and Jan 31, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USE WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, THE BLADE HAD SHAKE. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT STILL HAD OBVIOUS SHAKE. FINALLY, THE DOCTOR CHANGED A NEW BLADE AND THE BLADE COULD FUNCTION NORMALLY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281251 ↗
• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING BUT IT WAS WOBBLING. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT STILL HAD OBVIOUS SHAKE. FINALLY, THE DOCTOR CHANGED A NEW BLADE AND THE BLADE COULD FUNCTION NORMALLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280707 ↗
• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO USE, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, IT WAS FOUND THAT THE TIP OF BLADE HAD OBVIOUSLY SWAY. THE DOCTOR TRIED TO RECONNECT THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE TO PERFORM THE SURGERY. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249446 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE BLADE INNER TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED USING BACK UP PRODUCT. THE PATIENT STATUS IS REPORTED AS ALIVE WITH NO INJURY. THERE WERE NO FRAGMENTS/PIECES DETACH FROM THE BROKEN DEVICE. THE TIP BROKE AFTER USING FOR SOME TIME. WHEN THE PRODUCT WAS RETURNED FOR ANALYSIS, THE INNER SHAFT WAS BROKE OFF AND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835835 ↗
• MalfunctionMar 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT THE INNER BLADE OF THE PRODUCT HAD A METAL COATING WHICH BEGAN TO FLAKE OFF WHILE THE PRODUCT WAS BEING USED INSIDE THE SINUS CAVITY DURING HIS 4TH CASE. THE BLADE WAS REMOVED AND REPLACED WITH A NEW BLADE, WHICH WAS FROM THE SAME LOT AND HAD THE SAME ISSUE AGAIN. UPON FOLLOW UP IT WAS STATED THAT FRAGMENTS WERE NOTICED IN THE NASAL PASSAGE. THERE WAS NO PATIENT IMPACT. A 2ND BACK UP DEVICE FROM ANOTHER LOT# WAS USED TO COMPLETE THE PROCEDURE. THERE WERE DELAYS IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398591 ↗
• MalfunctionMar 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT THE INNER BLADE OF THE PRODUCT HAD A METAL COATING WHICH BEGAN TO FLAKE OFF WHILE THE PRODUCT WAS BEING USED INSIDE THE SINUS CAVITY DURING HIS 4TH CASE. THE BLADE WAS REMOVED AND REPLACED WITH A NEW BLADE, WHICH WAS FROM THE SAME LOT AND HAD THE SAME ISSUE AGAIN. UPON FOLLOW UP IT WAS STATED THAT FRAGMENTS WERE NOTICED IN THE NASAL PASSAGE. THERE WAS NO PATIENT IMPACT. A 2ND BACK UP DEVICE FROM ANOTHER LOT# WAS USED TO COMPLETE THE PROCEDURE. THERE WERE DELAYS IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398553 ↗
• MalfunctionSep 22, 2017Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT PREOPERATIVE, THE BLADE TIP BROKE OFF. THE BREAK DID NOT RESULT IN A FRAGMENT THAT REQUIRED RETRIEVAL FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6887244 ↗
• MalfunctionJan 3, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PRE-OPERATIVE A TIP OF THE TURBINATE BLADE BROKE OFF WHILE PRIMING THE BLADE. THERE WERE NO FRAGMENTS THAT FELL INTO THE PATIENT. ANOTHER BLADE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6219204 ↗