N/A 1883070BLDRecalls & reported problems
Medtronic Xomed, Inc. · BUR 1883070BLD DIAMOND 70DG 3MM 13CM 30K · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169434622), received between Feb 28, 2022 and Aug 4, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
Device problems
- Break2
- Vibration1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2023Vibration; Vibration
IT WAS REPORTED THAT INTRA-OPERATIVE DURING THE FESS PROCEDURE THE BLADE SPUN IN THE MICRODEBRIDER INSTEAD OF STAYING LOCKED IN PLACE. THE DEVICE CHECKED FOR VIBRATION/WOBBLE PRIOR TO USE. THE VIBRATING DEVICE WAS USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP PRODUCT. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17459542 ↗MalfunctionMar 7, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED THAT THE BUR BROKE WHILE IN USE AND SURGEON FELT SOMETHING POP WHILE USING IT. THE HEAD OF THE BUR IS INTACT AND NO FRAGMENTS/PIECES DETACHED FROM THE BROKEN DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16493754 ↗MalfunctionFeb 28, 2022Break; Break
IT WAS REPORTED THAT DURING PRE-OP BLADE/BUR NOT SEATING AND THE BUR WAS STUCK. THERE WAS NO PATIENT INVOLVED. ON FOLLOW-UP, IT WAS REPORTED THAT THE HANDPIECE WAS A DEMO DEVICE. THE DEVICE WAS ONLY BORROWED TO THE CUSTOMER AS BACKUP DEVICE. SERVICE AND REPAIR FOUND THAT THERE WAS PIECE OF BUR IN THE COLLET. ON FURTHER FOLLOW-UP IT WAS REPORTED THAT THE BUR WAS BROKEN WHILE USED ON PATIENT AND THE OPERATOR COULDN¿T REMOVE THE BUR AFTER THE ACCIDENT. IT¿S DIFFICULT TO EVALUATE BUT PROBABLY THE REAR END. THE PART THAT¿S INSIDE THE HANDPIECE. NO FRAGMENTS THAT CAME OFF OR GOT DETACHED FROM THE BROKEN DEVICE. NO FRAGMENT GET IN CONTACT WITH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13616823 ↗
Other BUR, EAR, NOSE AND THROAT devices
- Quadcut® 1884380HRMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall7 reports
- Silver Bullet® 1882905HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall3 reports
- Diego Elite MBUR6060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall2 reports
- Quadcut® 1884380HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- RAD® 1882916Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- N/A 1884032Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
- DIEGO ELITE MBUR5060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884033HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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