Quadcut 1884080EMRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000579241), received between Dec 26, 2023 and Jan 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Vibration” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Vibration; Vibration

  IT WAS REPORTED THAT WHILE USING THE M5 HANDPIECE TO SEE IF THE BLADE WAS WELL ATTACHED, THE DOCTOR FELT THAT THE BLADE WAS VIBRATING A LOT. THERE WAS NO PATIENT INVOLVED. THE SHAVER WAS VIBRATING A LOT FROM THE BEGINNING OF THE SURGERY BUT IT DID NOT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21250739 ↗
• MalfunctionSep 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PRE-OP, THE HUB THAT CONNECTS THE TRACKING CABLE TO THE BLADE BECAME DISCONNECTED AND CAN SLIDE ALONG THE BLADE SHAFT. THIS CAME DISCONNECTED OUT OF THE BOX. IT WAS NOT USED ON A PATIENT. THEY OPENED A NEW ONE FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20243375 ↗
• MalfunctionMay 24, 2024Mechanical Problem; Vibration; Mechanical Problem; Vibration

  IT WAS REPORTED THAT INTRA-OP, BLADES WERE WOBBLING. THERE WAS LESS THAN A HOUR DELAY IN PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393344 ↗
• MalfunctionMay 24, 2024Mechanical Problem; Vibration; Mechanical Problem; Vibration

  IT WAS REPORTED THAT INTRA-OP, BLADES WERE WOBBLING. THERE WAS LESS THAN A HOUR DELAY IN PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393289 ↗
• MalfunctionApr 29, 2024Vibration; Vibration

  IT WAS REPORTED THAT DURING INTRA-OP, THE TRICUT BLADE WAS WOBBLING. THERE WAS A SURGICAL DELAY OF 20 MINUTES. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THE PATIENT STATUS IS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED STATING THAT BLADE WAS NOT CHECKED PRIOR TO USE FOR WOBBLE. THE BLADE WOBBLED DURING INITIAL USE. FESS PROCEDURE WAS BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19199810 ↗
• MalfunctionDec 26, 2023Break; Overheating of Device; Break; Overheating of Device

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE BLADE DID NOT DETACH INSIDE THE PATIENT. THE PRODUCT WAS MELTED ON THE EXITING SINUS WHILE INSIDE THE PATIENT AND WAS QUICKLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392171 ↗