Quadcut® 1884380HR (UDI 20763000038162)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20763000038162), received between Apr 2, 2021 and May 28, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Vibration” (5 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 31, 2021Open, Classified

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

   Z-0156-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2021Vibration; Vibration

  IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL THAT THE DEVICE WAS WOBBLY DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THE PROCEDURE WAS COMPLETED BY A BACK UP DEVICE WITH 5 MINUTES DELAY. THE DEVICE HAD IN CONTACT WITH THE PATIENT. THERE WAS NO TROUBLESHOOTING DONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901206 ↗
• MalfunctionMay 12, 2021Vibration; Vibration

  ON FOLLOW UP, IT WAS REPORTED THAT THE CUSTOMER TRIED TO REPOSITION THE BLADE. THE EVENT HAPPENED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812199 ↗
• MalfunctionApr 29, 2021Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BLADE WOBBLED INTRA-OPERATIVELY. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. THE PATIENT WAS ALIVE - NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11744012 ↗
• MalfunctionApr 23, 2021Vibration; Vibration

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT BLADE SHAKING, VIBRATING WHILE SECURED IN HANDPIECE DURING FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THEY HAD TO OPEN UP A NEW BLADE. THERE WAS NO PATIENT IMPACT. THE PROCEDURE WAS EXTENDED FOR 10 MINUTES AND COMPLETED WITH THE REPORTED PRODUCT. THE SHAKING BLADE WAS USED ON THE PATIENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716396 ↗
• MalfunctionApr 16, 2021Vibration; Vibration

  ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11677889 ↗
• MalfunctionApr 2, 2021Break; Break

  ON FOLLOW UP IT WAS REPORTED THAT THERE IS NO PATIENT HARM/PATIENT INVOLVEMENT, BUT THERE WAS ABOUT TWO MINUTE PROCEDURE DELAY. NO FRAGMENTS, CLEAN BREAK WHERE THE METAL AND PLASTIC MEET. WHITE BASE WITH SOME METAL STICKING OUT, PIECE OF SHAFT. ONE OF THEM IS 1/2 INCH STICKING OUT. OTHER FULL SHAFT WITH TIP AND COMPLETE WHITE ROUND SHAPE AROUND THE BOTTOM PART OF IT. THE DEVICE WAS USED UNTIL IT BROKE AND THEN GOT A REPLACEMENT TO FINISH THE PROCEDURE. BACK UP DEVICE WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607663 ↗
• MalfunctionApr 2, 2021Break; Break

  ON FOLLOW UP IT WAS REPORTED THAT THERE WAS NO PATIENT HARM/PATIENT INVOLVEMENT, BUT THERE WAS ABOUT TWO MINUTE PROCEDURE DELAY. NO FRAGMENTS, CLEAN BREAK WHERE THE METAL AND PLASTIC MEET. WHITE BASE WITH SOME METAL STICKING OUT, PIECE OF SHAFT. ONE OF THEM IS 1/2 INCH STICKING OUT. OTHER FULL SHAFT WITH TIP AND COMPLETE WHITE ROUND SHAPE AROUND THE BOTTOM PART OF IT. THE DEVICE WAS USED UNTIL IT BROKE AND THEN GOT A REPLACEMENT TO FINISH THE PROCEDURE. BACK UP DEVICE WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11607637 ↗