ENT MR8 1847B50SCCRecalls & reported problems
Medtronic Powered Surgical Solutions · BUR 1847B50SCC ENTMR8 CUT CBD 5MM STD · Class 2
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 00763000753795), received between Mar 10, 2026 and Mar 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- Insufficient Information1
- 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.
MalfunctionMar 10, 2026Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE BONE MILLING, THE HEAD OF THE DRILL BIT CAME LOOSE AND FLEW AROUND THE ROOM. AT THE TIME OF THE REPORT, THERE WAS NO KNOWN IMPACT TO A PATIENT. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT IMPACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24554949 ↗
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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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