Quadcut 1884380EMRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00763000579272), received between Aug 10, 2022 and Aug 11, 2025 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE, INSTRUMENT CAME APART UNEXPECTEDLY. THE EVENT OCCURRED DURING ACTIVE USE ON A PATIENT. THE HANDPIECE CAME APART. NO FRAGMENT LEFT ON PATIENT. THE COMPONENT SEPARATED WITHOUT EXCESSIVE FORCE USE ON PATIENT OR IMPROPER HANDLING. THE PROCEDURE PAUSED TO ADDRESS THE ISSUE AND ENSURE PATIENT SAFETY. THE DEVICE WAS IMMEDIATELY REMOVED, LABELLED AND SENT TO CORE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22769144 ↗
• MalfunctionJul 8, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PROCEDURE PERFORMED WAS BILATERAL IMAGE-GUIDED ENDOSCOPIC SINUS SURGERY (BIGESS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434812 ↗
• MalfunctionJul 4, 2025Break; Break

  IT WAS REPORTED, THE SURGEON OBSERVED THAT THE BLADE WAS NO LONGER ROTATING UPON ACTIVATION WITH THE FOOT PEDAL. THE SCRUB TECHNICIAN ATTEMPTED TO REMOVE THE BLADE FROM THE HANDPIECE AND CONFIRMED THAT THE BLADE DID NOT BREAK DURING REMOVAL. IT WAS NOTED THAT THE BLADE HAD BROKEN PRIOR TO THIS ATTEMPT, THE INNER BLADE BROKE APART AND FELL OFF. THE PROCEDURE WAS COMPLETED USING A ANOTHER BLADE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401655 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT DURING SINUS SURGERY, THE END CAME OFF OF THE BLADE NEAR WHERE THE CORD INSERTS. THERE WERE NO BROKEN PIECES REMAINING INSIDE THE PATIENT BODY. THE PROCEDURE WAS COMPLETED USING A BACK UP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967837 ↗
• MalfunctionMar 30, 2025Break; Break

  IT WAS REPORTED THAT INTRA OPERATIVELY WHILE PERFORMING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE QUADCUT BLADE WASN'T WORKING RIGHT THEN THE BLADE BROKE OFF. THERE WERE NO FRAGMENTS OR PIECES DETACHED FROM THE BROKEN DEVICE. THERE WAS NO DELAY IN THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21728603 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, BLADE BROKEN. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE IS NO PATIENT IMPACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675350 ↗
• MalfunctionMar 14, 2025Vibration; Vibration

  IT WAS REPORTED DURING PITUITARY TUMOR RESECTION, SURGEON ACTIVATED BLADE AT 5000 RPM OSCILLATING MODE AND THERE WAS EXCESSIVE BLADE WOBBLE AND VIBRATION, A NEW BLADE WAS REPLACED AND WORKED AS EXPECTED. THE PROCEDURE WAS EXTENDED FOR 5 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606284 ↗
• MalfunctionMar 10, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING PROCEDURE, SHAVER THE BLADE GOT STUCK AND WAS BROKEN IN SHAFT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557470 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A FESS CASE WHILE USING THE QUADCUT BLADE, THE BLADE BROKE OFF AT THE BASE (BETWEEN THE INNER BASE THAT GOES INTO THE THICKER BASE). ENT REP REPORTED THIS DID NOT IMPACT THE PATIENT. SITE OPENED UP ANOTHER QUADCUT BLADE AND REPORTED THAT ONE ALSO BROKE AT THE BASE. SITE REPORT THIS SECOND HAPPENED WHEN SETTING UP THE BLADE AND NOT USED ON PATIENT. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400271 ↗
• MalfunctionJan 31, 2025Vibration; Vibration

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SHAVER BLADE WAS LOADED INTO THE SHAVER, DOCTOR TESTED BLADE AND IT WOBBLED AT THE TIP AND WAS UNUSABLE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21280842 ↗
• MalfunctionDec 30, 2024Vibration; Vibration

  IT WAS REPORTED THAT THERE WAS NO NOTICEABLE DAMAGE ON THE PRODUCT OR ITS PACKAGE. DURING PROCEDURE, WHEN THE DR. WENT TO USE THE QUADCUT BLADE HE NOTICED THAT IT WAS NOT ACTUALLY WORKING AND THAT THE ENTIRE BLADE ITSELF WAS SHAKING WHEN IN USE. IT WAS DISCOVERED THAT THE INNER BLADE WAS STUCK IN PLACE AND NOT ROTATING. INSTEAD OF TRYING A NEW QUADCUT BLADE, HE USED A RAD BLADE THAT WORKED WELL AND NO FURTHER ISSUES OCCURRED DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21033329 ↗
• MalfunctionOct 21, 2024Use of Device Problem; Vibration; Use of Device Problem; Vibration

  IT WAS REPORTED THAT INTRA-OP, THE BLADE WAS SPINNING WAY TOO FAST AND OUT OF CONTROL FOR USE. IT WAS BEING USED AT 5000RPM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490547 ↗
• MalfunctionOct 8, 2024Vibration; Vibration

  IT WAS REPORTED THAT WHEN THE DEVICE WAS TESTED PRIOR TO ENTERING THE SURGICAL SITE(NOSTRILS), THE BLADE WAS SEATED PROPERLY, BUT THE TIP OF THE BLADE WAS VIBRATING AND OUT OF CONTROL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20398116 ↗
• MalfunctionSep 18, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING PROCEDURE SURGEON USED SLIGHT TORQUE TO DIRECT BLADE AS USUAL IN THE SINUS CASE AND BLADE BROKE. THE PRODUCT WAS REPLACED WITH ANOTHER QUADCUT BLADE AND THERE WAS DELAY OF 5 MINUTES IN PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20243328 ↗
• MalfunctionMay 27, 2024Break; Contamination; Break; Contamination

  IT WAS REPORTED THAT PACKAGE WAS OPENED FOR FESS PROCEDURE AND NOTICED DAMAGE TO BACK PORTION. NOTICEABLE EXTERNALLY AND INTERNALLY. USER WAS NOT COMFORTABLE USING DEVICE DUE TO POSSIBLE CONTAMINATION. THERE WAS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19399419 ↗
• MalfunctionApr 8, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE BROKEN PART REMAINED IN THE M4 HANDPIECE UNTIL TAKEN OUT. FRAGMENTS DID NOT FALL INTO PATIENT. THERE WAS A PROCEDURAL DELAY OF THIRTY MINUTES. THE BLADE WAS RUN AT A SPEED OF 5000 RPM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057338 ↗
• MalfunctionApr 8, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE BROKEN PART REMAINED IN THE M4 HANDPIECE UNTIL TAKEN OUT. FRAGMENTS DID NOT FALL INTO PATIENT. THERE WAS A PROCEDURAL DELAY OF THIRTY MINUTES. THE BLADE WAS RUN AT A SPEED OF 5000 RPM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057329 ↗
• MalfunctionApr 8, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE BROKEN PART REMAINED IN THE M4 HANDPIECE UNTIL TAKEN OUT. FRAGMENTS DID NOT FALL INTO PATIENT. THERE WAS A PROCEDURAL DELAY OF THIRTY MINUTES. THE BLADE WAS RUN AT A SPEED OF 5000 RPM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057319 ↗
• MalfunctionMar 20, 2024Vibration; Vibration

  IT WAS REPORTED THAT PRIOR TO THE CASE OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE EM QUADCUT 4.3MM, STARTED "VIBRATING QUITE BLATANTLY." THE CONNECTION WAS RESEATED AND LOWERED THE SPEED WITHOUT RESOLUTION. SITE TRIED A NEW INSTRUMENT AND WORKED AS DESIGNED. THERE WAS A PROCEDURAL DELAY OF LESS THAN ONE HOUR AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941043 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT ROTATABLE FUSION BLADE CAME APART DURING CASE. THERE IS NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837104 ↗
• MalfunctionJan 2, 2024Break; Vibration; Break; Vibration

  IT WAS REPORTED THAT DURING ENDOSCOPIC ETHMOIDECTOMY PROCEDURE, A SMALL PIECE OF BLADE HUB/ PLASTIC CAME APART OUTSIDE THE PATIENT. THERE WAS A DELAY OF 5 MINUTES. PROCEDURE WAS COMPLETED WITH ANOTHER BLADE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18426074 ↗
• MalfunctionDec 14, 2023Break; Break

  IT WAS REPORTED THAT IN A SINUS CASE BLADE BROKE OFF AFTER USAGE ON THE FIELD. NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18324484 ↗
• MalfunctionNov 22, 2023

  DURING NAVIGATED SINUS SURGERY A MEDTRONIC NAVIGATED QUADCUT MICRODEBRIDER BLADE STOPPED FUNCTIONING. THE BLADE WAS NOT IN DIRECT PATIENT USE WHEN THE BLADE WAS FOUND TO BE NOT WORKING. THE HUB ASSEMBLY JUST PRIOR TO THE BLADE SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190754 ↗
• MalfunctionOct 20, 2023Vibration; Vibration

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE QUADCUT BLADES WERE WOBBLY. THEY STARTED OFF FINE BUT BECAME WOBBLY THE MORE THEY WERE USED IN THE PROCEDURE, REPLACED ONE NAV QUADCUTS WITH ANOTHER. THE NEW NAV QUADCUT WAS WOBBLY FROM THE BEGINNING OF USE, EVENTUALLY REPLACED BOTH WITH A TRICUT NON NAVIGATED. ALSO TRIED A SECOND M4 HANDPIECE AND THIS DID NOT FIX THE ISSUE. THE TRICUT BLADE WORKED PERFECTLY. TRIED THE TRICUT BLADE IN THE FIRST HANDPIECE AND IT WORKED FINE IN BOTH HANDPIECES SO IT WAS DETERMINED THE ISSUE WAS WITH THE BLADES AND NOT THE M4S. THE PROCEDURE WAS DELAYED BY 15 MINUTES AND COMPLETED WITH BACKUP PRODUCT WITHOUT ANY INTERVENTION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17972101 ↗
• MalfunctionOct 20, 2023Vibration; Vibration

  IT WAS REPORTED THAT DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY, THE QUADCUT BLADES WERE WOBBLY. THEY STARTED OFF FINE BUT BECAME WOBBLY THE MORE THEY WERE USED IN THE PROCEDURE, REPLACED ONE NAV QUADCUTS WITH ANOTHER. THE NEW NAV QUADCUT WAS WOBBLY FROM THE BEGINNING OF USE, EVENTUALLY REPLACED BOTH WITH A TRICUT NON NAVIGATED. ALSO TRIED A SECOND M4 HANDPIECE AND THIS DID NOT FIX THE ISSUE. THE TRICUT BLADE WORKED PERFECTLY. TRIED THE TRICUT BLADE IN THE FIRST HANDPIECE AND IT WORKED FINE IN BOTH HANDPIECES SO IT WAS DETERMINED THE ISSUE WAS WITH THE BLADES AND NOT THE M4S. THE PROCEDURE WAS DELAYED BY 15 MINUTES AND COMPLETED WITH BACKUP PRODUCT WITHOUT ANY INTERVENTION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17972100 ↗