Fusion® Quadcut® 1884380EMRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000034023), received between Nov 18, 2020 and Dec 20, 2023 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Vibration” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 31, 2021Open, Classified

   There was an increase in complaints related to tip breaks and wobble/vibration.

   Z-0157-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2023Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY THREE QUADCUT BLADES HAD CHATTERING (WOBBLING) ISSUES, REMOVED BLADES, REPLACED, TRIED AGAIN BUT STILL IT WAS CHATTERING, CHANGED HADPIECE BUT STILL IT WAS CHATTERING. USER CHANGED TO A NEW BLADE RAD40 BLADE IT WAS NOT CHATTERING, BUT IT BROKE AT THE DISTAL TIP WHILE BEING USED ON THE PATIENT. THE TIP SPRUNG OUT AS SOON AS THE USER PUT IT IN THE PATIENT AND INITIATED THE BLADE TO BEGIN SHAVING. USER USED BALDE FROM DIFFIRENT LOT IT WAS NOT CHATTERING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361654 ↗
• MalfunctionDec 20, 2023Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY THREE QUADCUT BLADES HAD CHATTERING (WOBBLING) ISSUES, REMOVED BLADES, REPLACED, TRIED AGAIN BUT STILL IT WAS CHATTERING, CHANGED HADPIECE BUT STILL IT WAS CHATTERING. USER CHANGED TO A NEW BLADE RAD40 BLADE IT WAS NOT CHATTERING, BUT IT BROKE AT THE DISTAL TIP WHILE BEING USED ON THE PATIENT. THE TIP SPRUNG OUT AS SOON AS THE USER PUT IT IN THE PATIENT AND INITIATED THE BLADE TO BEGIN SHAVING. USER USED BALDE FROM DIFFIRENT LOT IT WAS NOT CHATTERING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361650 ↗
• MalfunctionOct 4, 2021Vibration; Vibration

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT THE BLADES WERE WOBBLY DURING USE. THEY OPENED A SECOND BUR AND OBSERVED SAME RESULTS. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) WITH 10 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568748 ↗
• MalfunctionOct 4, 2021Vibration; Vibration

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT THE BLADES WERE WOBBLY DURING USE. THEY OPENED A SECOND BUR AND OBSERVED SAME RESULTS. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) WITH 10 MINUTES DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568730 ↗
• MalfunctionJun 2, 2021Vibration; Vibration

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE BLADE WAS VIBRATING EXCESSIVELY WHEN FOOT PEDAL WAS ACTIVATED. ANOTHER HANDPIECE WAS OPENED, SAME BLADE VIBRATION WAS EXPERIENCED, THEN NEW BLADE WITH SAME PRODUCT NUMBER WAS OPENED AND FUNCTIONED NORMALLY WITHOUT THE VIBRATION ISSUE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THERE WAS NO PATIENT IMPACT. UPON FOLLOW UP IT WAS REPORTED THAT THE VIBRATING DEVICE WAS USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920716 ↗
• MalfunctionMay 20, 2021Vibration; Vibration

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT BLADE WAS VIBRATING MORE THAN NORMAL DURING ENDOSCOPIC SINUS SURGERY. THE SURGICAL TECH THEN RE-SEATED THE BLADE BUT STILL HAD VIBRATING ISSUE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THE BLADE VIBRATED BEFORE AND DURING USE ON PATIENT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION FROM REP REPORTED THAT THERE WERE TWO BLADES OPENED WITH THE SAME ISSUE IN WHICH BOTH VIBRATED BEFORE AND DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11854259 ↗
• MalfunctionMay 18, 2021Vibration; Vibration

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT BLADE WAS VIBRATING MORE THAN NORMAL DURING ENDOSCOPIC SINUS SURGERY. THE SURGICAL TECH THEN RE-SEATED THE BLADE BUT STILL HAD VIBRATING ISSUE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THE BLADE VIBRATED BEFORE AND DURING USE ON PATIENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841153 ↗
• MalfunctionApr 30, 2021Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE BLADE CHATTERED DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY WITH IMAGE GUIDANCE PROCEDURE. THE BLADE WAS BEING USED ON THE PATIENT WHEN IT CHATTERED. THEY CHANGED THE HANDPIECE AND CONSOLE AND STILL IT CHATTERED. THEY CHANGED TO A NEW BLADE WITH A DIFFERENT LOT NUMBER AND NO CHATTERING OCCURRED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752988 ↗
• MalfunctionApr 21, 2021Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT WHILE THE DOCTOR WAS FIRST NAVIGATING, HE COMPLAINED OF THE BLADE VIBRATING DURING A (FESS) FUNCTIONAL ENDOSCOPIC SINUS SURGERY. A SECOND BLADE WAS OPENED WITH THE SAME LOT NUMBER AND IT CONTINUED TO HAVE VIBRATION ISSUES. BOTH DEVICES HAD CONTACT WITH THE PATIENT. A THIRD BLADE WAS OPENED WITH A DIFFERENT LOT NUMBER, AND THE PRODUCT WORKED WITHOUT ISSUES. THERE WAS A FIVE MINUTE DELAY FROM THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702982 ↗
• MalfunctionApr 21, 2021Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT WHILE THE DOCTOR WAS FIRST NAVIGATING, HE COMPLAINED OF THE BLADE VIBRATING DURING A (FESS) FUNCTIONAL ENDOSCOPIC SINUS SURGERY. A SECOND BLADE WAS OPENED WITH THE SAME LOT NUMBER AND IT CONTINUED TO HAVE VIBRATION ISSUES. BOTH DEVICES HAD CONTACT WITH THE PATIENT. A THIRD BLADE WAS OPENED WITH A DIFFERENT LOT NUMBER, AND THE PRODUCT WORKED WITHOUT ISSUES. THERE WAS A FIVE MINUTE DELAY FROM THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702897 ↗
• MalfunctionApr 13, 2021Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT AS SOON AS THE PHYSICIAN STARTED PUSHING ON THE FOOT CONTROL HE NOTICED THE SHAVER TIP VIBRATING. THE DOCTOR CHECKED THE DEVICE FOR PROPER ASSEMBLY INTO THE HAND PIECE. HE RAN THE DEVICE AGAIN AND IT WAS STILL VIBRATING. THE STAFF OPENED ANOTHER SHAVER BLADE AND THE SAME VIBRATING OCCURRED. A SECOND HAND PIECE WAS OPENED AND AGAIN THERE WAS VIBRATION. THE REPRESENTATIVE WAS ABLE TO FIND A NEW LOT NUMBER OF THE SAME PRODUCT AND THE BLADE WAS INSERTED AND WORKED AS INTENDED DURING THE BILATERAL SINUS SURGERY. THERE WAS NO PATIENT IMPACT AND NO INTERVENTION. A 10 MINUTE DELAY WAS RECORDED. ON FOLLOW UP IT WAS REPORTED THAT VIBRATION WAS DISCOVERED ONCE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656218 ↗
• MalfunctionApr 9, 2021Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE BLADE CHATTERED DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY WITH IMAGE GUIDANCE PROCEDURE. THE BLADES WAS BEING USED ON THE PATIENT WHEN IT CHATTERED. THEY CHANGED THE HANDPIECE AND CONSOLE AND STILL IT CHATTERED. THEY CHANGED TO A NEW BLADE WITH A DIFFERENT LOT NUMBER AND NO CHATTERING OCCURRED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640286 ↗
• MalfunctionApr 6, 2021Vibration; Vibration

  ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THE BLADE WAS BEING USED ON THE PATIENT WHEN IT CHATTERED DURING THE FUNCTIONAL ENDOSCOPIC SINUS SURGERY WITH IMAGE GUIDANCE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618933 ↗
• MalfunctionMar 25, 2021Vibration; Vibration

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT AS SOON AS THE PHYSICIAN STARTED PUSHING ON THE FOOT CONTROL HE NOTICED THE SHAVER TIP VIBRATING. THE DOCTOR CHECKED THE DEVICE FOR PROPER ASSEMBLY INTO THE HAND PIECE. HE RAN THE DEVICE AGAIN AND IT WAS STILL VIBRATING. THE STAFF OPENED ANOTHER SHAVER BLADE AND SAME VIBRATION OCCURRED. A SECOND HAND PIECE WAS OPENED AND AGAIN THERE WAS VIBRATION. THE REPRESENTATIVE WAS ABLE TO FIND A NEW LOT NUMBER OF THE SAME PRODUCT AND THE BLADE WAS INSERTED AND WORKED AS INTENDED DURING THE BILATERAL SINUS SURGERY. THERE WAS NO PATIENT IMPACT NO AND NO INTERVENTION. A 10 MINUTE DELAY WAS RECORDED. ON FOLLOW UP IT WAS REPORTED THAT VIBRATION WAS DISCOVERED ONCE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11568224 ↗
• MalfunctionMar 20, 2021Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT WHEN THEY TRIED USING THE TWO DIFFERENT BLADES DURING A CASE, THE BLADE GOT REALLY BAD VIBRATING AND WERE UNABLE TO USE THE BLADES. BOTH BLADES HAD THE SAME LOT NUMBER AND WHEN THEY SWITCHED TO A DIFFERENT LOT NUMBER, THE ISSUE WAS RELIEVED. THEY ALSO SWITCHED OUT THE SHAVER. IT WAS ALSO MENTIONED THAT THE CUSTOMER DOESN¿T THINK THE ISSUE IS WITH THE SHAVER AND ONLY THE BLADES. THERE WAS NO KNOWN PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT HAPPENED WHEN THEY PLUGGED INTO THE CONSOLE AND STARTED TO USE THE BLADE ON THE PATIENT AND NOTICED THE VIBRATION DURING A PROCEDURE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536527 ↗
• MalfunctionMar 20, 2021Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT WHEN THEY TRIED USING THE TWO DIFFERENT BLADES DURING A CASE, THE BLADE GOT REALLY BAD VIBRATING AND WERE UNABLE TO USE THE BLADES. BOTH BLADES HAD THE SAME LOT NUMBER AND WHEN THEY SWITCHED TO A DIFFERENT LOT NUMBER, THE ISSUE WAS RELIEVED. THEY ALSO SWITCHED OUT THE SHAVER. IT WAS ALSO MENTIONED THAT THE CUSTOMER DOESN¿T THINK THE ISSUE IS WITH THE SHAVER AND ONLY THE BLADES. THERE WAS NO KNOWN PATIENT IMPACT. ON FOLLOW-UP, IT WAS REPORTED THAT THE EVENT HAPPENED WHEN THEY PLUGGED INTO THE CONSOLE AND STARTED TO USE THE BLADE ON THE PATIENT AND NOTICED THE VIBRATION DURING A PROCEDURE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536525 ↗
• MalfunctionMar 12, 2021Vibration; Vibration

  A MANUFACTURER REPRESENTATIVE REPORTED THAT A BLADE VIBRATED AT AN UNSTEADY RATE DURING AN ENDOSCOPIC SINUS SURGERY (ESS). IT WAS RESEATED AND THE BLADE STILL NO CHANGE IN THE EXCESSIVE VIBRATION. GRABBED ANOTHER BLADE AND IT FUNCTIONED PROPERLY. THERE WAS NO PATIENT IMPACT. AFTER SURGERY WAS COMPLETED SUCCESSFULLY, GRABBED A COUPLE MORE BLADES OFF THEIR INVENTORY SHELF TO PERFORM TESTING AND SEE IF THERE WAS THE SAME PROBLEM. ALSO OBSERVE THE SAME EXCESSIVE VIBRATION ON TWO OTHER BLADES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474214 ↗
• MalfunctionNov 18, 2020Break; Break

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT A DEVICE'S PIECE OF INSERT IN THE HANDLE BROKE DURING THE CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10862924 ↗