E9000 E8230LSORecalls & reported problems
Conmed Corporation · 3 X 48mm E9000 Fluted Low Speed Optimum Bur, Round, Carbide · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854010426), received between Nov 14, 2024 and Nov 14, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2024Material Fragmentation; Material Fragmentation
A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE E8230LSO, E9000 FLUTED LOW SPEED OPTIMUM BUR, ROUND, CARBIDE, 3 X 48 MM DEVICE WAS USED IN AN EAR PROCEDURE ON (B)(6)2024, AND ¿DURING A ENT SURGERY, SURGEON WAS USING COOLFLEX WITH OUR BUR WHEN THE HEAD OF THE BUR BROKE INSIDE THE PATIENT. FORTUNATELY, THEY CAN REMOVED WITH NO ISSUES FOR THE PATIENT.". THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE, AND A DELAY OF 15 MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20682856 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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