N/A 1882040Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 20681490613280), received between Oct 9, 2017 and Jan 31, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Vibration” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, HE FOUND THE BLADE HAS OBVIOUSLY SWUNG. THE DOCTOR TRIED TO REINSTALL BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW BLADE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281234 ↗
• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT, PRE-OP, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, IT WAS SHAKING. 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 21280653 ↗
• MalfunctionJan 30, 2025Vibration; Vibration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21270937 ↗
• MalfunctionJan 29, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHEN THE USER INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, USER FOUND THAT THE BLADE HAD VISIBLY SWAY. THE USER RECONNECT THE BLADE BUT USELESS. ANOTHER BLADE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261656 ↗
• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT PREOPERATIVE, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, FOUND THAT THE BLADE HAD OBVIOUS SHAKE. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A BLADE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251472 ↗
• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, FOUND THAT THE BLADE WAS WOBBLING OR VIBRATING, WHICH WILL PREVENT THE DOCTOR FROM RESECTING ACCURATELY. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A BLADE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21250656 ↗
• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT PREOPERATIVE, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, HE FOUND THAT THE BLADE HAD OBVIOUS SWAY. THE DOCTOR TRIED TO REINSTALL THE BLADE BUT USELESS. FINALLY, THE DOCTOR CHANGED A BLADE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21250336 ↗
• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT PREOPERATIVE, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, 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 WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249510 ↗
• MalfunctionMar 18, 2024Vibration; Vibration

  IT WAS REPORTED THAT BLADE WAS WOBBLING. PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCT. THERE WAS TWO MINUTES DELAY IN SURGERY AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18919840 ↗
• MalfunctionFeb 5, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING PRE-OP, WHEN THE DOCTOR INSTALLED THE BLADE INTO THE HANDPIECE FOR TESTING, HE FOUND THAT THE BLADE HAD OBVIOUSLY SWAYED. 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. THE SERVICE AND REPORT FOUND THAT THE BUR WAS WOBBLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18638056 ↗
• MalfunctionJun 2, 2021Vibration; Vibration

  A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REPORTED THAT THE BLADE WAS STALLING/SKIPPING DURING INFERIOR TURBINATE REDUCTION. THERE WAS 10 MINUTE DELAY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT. ON FOLLOW UP, WOBBLING OCCURRED WHILE BEING USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918879 ↗
• MalfunctionMay 28, 2021Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BLADE WOBBLED/VIBRATED SEVERELY WHEN BEING USED IN THE PATIENT DURING THE INFERIOR TURBINATE REDUCTION PROCEDURE. THEY CHANGED OUT THE BLADE AS PART OF THE TROUBLESHOOTING STEPS. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. THERE WAS A 5 MINUTES DELAY WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11902069 ↗
• MalfunctionMay 26, 2021Vibration; Vibration

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT THE DEVICE WOBBLED. THERE WAS NO PATIENT IMPACT. UPON FOLLOW UP IT WAS REPORTED THAT THE VIBRATING DEVICE WAS USED ON THE PATIENT AND WAS ABLE TO FINISH THE PROCEDURE USING THE REPORTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885433 ↗
• MalfunctionDec 30, 2020Material Separation; Material Separation

  ADDITIONAL INFORMATION RECEIVED THAT THE BROKEN PART OF THE BLADE WAS NEAR THE HUB. THERE WERE NO FRAGMENTS DETACHED FROM THE BLADE AND DID NOT COME IN CONTACT WITH THE PATIENT. THE BROKEN PART WAS CONTAINED IN THE HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095210 ↗
• MalfunctionDec 13, 2019Break; Break

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT A DEVICE BROKE WHILE ON INITIAL STAGE OF THE PROCEDURE. THE MODE IN THE CONSOLE WAS IN OSCILLATING MODE. A NEW BLADE WAS OPENED TO CONTINUE THE CASE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9465420 ↗
• MalfunctionJul 5, 2019Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT A BLADE WAS VIBRATING ALL THE TIME DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE DOCTOR NOTICED THAT THE BLADE WAS NOT VERY STEADY IN THE BEGINNING OF THE OPERATION. AFTER THE BLADE WAS USED FOR 5-10 MINUTES, THE DOCTOR FELT THAT THE VIBRATION WAS GETTING WORSE AND MIGHT INFLUENCE THE PRECISION OF THE OPERATION. HE TRIED TO REINSTALL THE BLADE BUT COULD NOT RESOLVE THE PROBLEM. AS A RESULT, THE DOCTOR USED ANOTHER BLADE TO COMPLETE THE SURGERY. THE SECOND BLADE FUNCTIONED PROPERLY WITH THE SAME HANDPIECE AND POWER SYSTEM. IT WAS THE INITIAL USE OF THE BLADE. THERE WAS NO ERROR CODE ON THE SCREEN OF THE POWER CONSOLE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764820 ↗
• MalfunctionApr 16, 2019Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA DISTRIBUTOR THAT AT THE BEGINNING OF THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY, HE NOTICED THAT THE BLADE VIBRATED EXCESSIVELY. THE SURGEON TRIED REINSTALLING THE BLADE HOWEVER THE PROBLEM STILL PERSISTED. AS A RESULT, THE DOCTOR USED A NEW BLADE TO COMPLETE THE OPERATION. THE SECOND BLADE FUNCTIONED PROPERLY WITHOUT VIBRATION USING THE SAME HANDPIECE. THERE WAS A PROCEDURE DELAY OF 3 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517857 ↗
• MalfunctionFeb 18, 2019Vibration; Vibration

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA A DISTRIBUTOR THAT AT THE MOST BEGINNING OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE DOCTOR NOTICED THAT THE BLADE VIBRATED ABNORMALLY. THE DOCTOR REINSTALLED THE BLADE BUT STILL COULD NOT RESOLVE THE PROBLEM. THEN, THE DOCTOR USED ANOTHER NEW BLADE TO COMPLETE THE PROCEDURE. THE SECOND BLADE COULD FUNCTION PROPERLY WITHOUT VIBRATION WITH THE SAME POWER SYSTEM. IT WAS THE INITIAL USE OF THE BLADE. THE PROCEDURE WAS DELAYED FOR ABOUT 5 MINUTES. NO ERROR CODE WAS DISPLAYED ON THE CONSOLE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8348258 ↗
• MalfunctionFeb 12, 2019Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT AT THE MOST BEGINNING OF THE OPERATION, THE DOCTOR NOTICED THAT THE BLADE VIBRATED. THE DOCTOR REINSTALLED THE BLADE BUT STILL COULD NOT RESOLVE THE PROBLEM. THEN, THE DOCTOR USED ANOTHER NEW BLADE TO COMPLETE THE OPERATION. THE SECOND BLADE COULD FUNCTION PROPERLY WITHOUT VIBRATION WITH THE SAME POWER SYSTEM. IT WAS THE INITIAL USE OF THE BLADE. THE PROCEDURE WAS A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) AND WAS DELAYED FOR ABOUT 5 MINUTES. NO ERROR CODE WAS DISPLAYED ON THE CONSOLE. THE DEVICE WAS USED ON THE PATIENT. THERE WAS NO PATIENT OR STAFF IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8331011 ↗
• MalfunctionFeb 7, 2019Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT AT THE MOST BEGINNING OF THE OPERATION, THE DOCTOR NOTICED THAT THE BLADE VIBRATED. THE DOCTOR REINSTALLED THE BLADE BUT STILL COULD NOT RESOLVE THE PROBLEM. ANOTHER NEW BLADE WAS USED TO COMPLETE THE OPERATION. THE SECOND BLADE COULD FUNCTION PROPERLY WITHOUT VIBRATION WITH THE SAME POWER SYSTEM. IT WAS THE INITIAL USE OF THE BLADE. THE SURGERY WAS A INFERIOR TURBINATE SURGERY AND WAS DELAYED FOR ABOUT 5 MINUTES. THERE WAS NO ERROR CODE DISPLAYED ON THE CONSOLE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8317633 ↗
• MalfunctionSep 21, 2018Use of Device Problem; Obstruction of Flow; Use of Device Problem; Obstruction of Flow

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE WAS NOT SUCTIONING DURING THE OPERATION. T HE BLADE WAS USED NORMALLY AND A CLEANER BRUSH WAS USED TO UNCLOG THE TUBE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7899505 ↗
• MalfunctionSep 18, 2018Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT THE BLADE'S BLUE PLASTIC WASHER WAS DISLODGED OFF AND BECAME WEDGED BETWEEN INNER AND OUTER SHAFT DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7887042 ↗
• MalfunctionOct 9, 2017Break; Break

  THE PHYSICIAN REPORTED THAT THE BLADE WAS BROKEN DURING THE SURGERY. NO FRAGMENT WAS LEFT IN THE PATIENT'S BODY. THERE WAS NO DELAY OF THE SURGERY. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6931270 ↗