Quadcut 1884006EMRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000579227), received between Mar 10, 2023 and Mar 20, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Break; Overheating of Device

  IT WAS REPORTED THAT 2 BLADES BROKE DURING THE PROCEDURE. ONE OF THEM, THE TIP BROKE OFF AND SPIRAL WRAP CAME OFF INSIDE THE PATIENT AS THE PHYSICIAN WAS USING IT AND HAD TO RETRIEVE IT USING TWEEZERS. THE OTHER ONE BROKE, THE ENTIRE SHAFT SEEMED TO GET TO WARM, AND THE SPIRAL SHAFT BEGAN TO COME OFF, BUT WAS REMOVED BEFORE IT BROKE OFF COMPLETELY AND CAN SEE WHERE IT IS ABOUT TO BREAK OFF. TIP OF FIRST BLADE WAS VERY HOT AND WAS ONLY USED A FEW MINUTES. WHILE USING THE SECOND BLADE, THE BLADE AND HANDPIECE BOTH BECAME HOT. THE BLADES WERE BEING USED IN OSCILLATION MODE AT NORMAL SPEED. THE PROCEDURE WAS COMPLETED WITH A THIRD BLADE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647154 ↗
• MalfunctionMar 20, 2026Break; Overheating of Device

  ADDITIONAL INFORMATION RECEIVED, THE HANDPIECE STARTED TO HEAT WITH IN A MINUTE PROBABLY 30 SECONDS OR LESS, IRRIGATION WAS USED (NORMAL SALINE) AND THE FLOW RATE WAS AT 3 CC/MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646838 ↗
• MalfunctionJul 1, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING STANDARD ENDOSCOPIC SINUS SURGERY, THE BLADE SOUNDED WEIRD AND THE TEETH WERE NOT LINING UP TO THE INSTRUMENT, POSSIBLY BENT. PRODUCT COULD NOT FUNCTION PROPERLY. THE 1ST SOUNDED WEIRD, AND THE TEETH WERE NOT LINING UP TO THE INSTRUMENT LIKE IT WAS BENT AND THE SECOND ONE WOULD NOT ROTATE. THE PROCEDURE WAS EXTENDED BY 10 MINUTES AND COMPLETED USING BACKUP PRODUCT. THERE WAS NO PATIENT INJURY. ANALYSIS OF THE PRODUCTS CONFIRMED THAT THE BLADES WERE BROKEN AND DETACHED WHEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19649998 ↗
• MalfunctionJul 1, 2024Break; Material Deformation; Noise, Audible; Break; Material Deformation; Noise, Audible

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE BLADES WERE BROKEN WHILE REMOVING FROM THE HANDPIECE AND NO FRAGMENTS CAME INTO THE CONTACT OF PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19647232 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT BLADE TIP CAME APART DURING SURGERY. THE PROCEDURE COMPLETED WITH THE BACK UP DEVICE. THERE WAS NO DELAY IN THE SURGERY AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719429 ↗
• MalfunctionApr 7, 2023Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, BLADE COME APART. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702334 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE BLADE CAME APART. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16694017 ↗
• MalfunctionMar 29, 2023Break; Break

  IT WAS REPORTED BY HEALTH CARE PROFESSIONAL THAT DURING PROCEDURE SHAVER TIP POPPED OUT OF ITS PLACE AND ROTATE. THERE WAS NO REPORTED PATIENT IMPACT. SHAVER FAILED TO LINE UP. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT THE DISTAL BLADE AND SUCTION PORT WAS LOOSE, PARTIALLY DETACHED AND SPONTANEOUSLY ROTATING WHILE IN USING AND WAS NOT SHAVING TISSUE. THE BLADE TIP AND SUCTION PORT WAS PARTIALLY DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633764 ↗
• MalfunctionMar 10, 2023Break; Noise, Audible; Break; Noise, Audible

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY WITH NASAL POLYPECTOMY PROCEDURE PHYSICIAN WAS USING THE BLADE IN THE PATIENT¿S MAXILLARY SINUS. A NOISE WAS HEARD AND THEY IMMEDIATELY NOTICED THAT THE TIP OF THE METAL SHAFT HAD BROKEN. THEY REMOVED THE BROKEN PIECE AND CONTINUED WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED AFTER FOLLOW UP THAT FRAGMENTS WAS DETACHED FROM THE BROKEN DEVICE AND PHYSICIAN VISUALLY REMOVED THE BROKEN TIP FROM THE PATIENT¿S SINUS. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16520632 ↗