ENT MR8 1847ATTASRecalls & reported problems
Medtronic Powered Surgical Solutions · ATTACHMENT 1847ATTAS ENTMR8 ANGLE STD · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic ENT MR8 drill attachment, used in ear, nose and throat surgery, has 137 adverse event reports, with no deaths or injuries. Some describe overheating, difficulty inserting the attachment, and parts that wear or detach. No recalls name this device. Reports rose to 106 over the last year from 21 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 143
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00763000356972), received between Aug 29, 2023 and Sep 30, 2026 — classified as 143 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (32 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event67
- Overheating of Device32
- Difficult to Insert23
- Naturally Worn10
- Detachment of Device or Device Component9
- Loss of Power6
- Noise, Audible6
- Difficult to Remove4
Patient problems
- No Clinical Signs, Symptoms or Conditions138
- Insufficient Information7
Recent adverse event reports
The 25 most recent of 143 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Apparent Adverse Event
Medtronic received information regarding a repair request, and no alleged product deficiencies were reported. It was unknown if there was any patient involvement or complications as a result of the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943354 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
Medtronic received information regarding a repair request and no alleged product deficiencies were reported. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911826 ↗MalfunctionSep 27, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910164 ↗MalfunctionSep 16, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788165 ↗MalfunctionSep 11, 2026Difficult to Insert
It was reported that the device was defective during use. It was reported that there was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50730748 ↗MalfunctionSep 9, 2026No Apparent Adverse Event
Medtronic received information regarding a repair request and no alleged product deficiencies were reported. At the time of the report, there was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50684693 ↗MalfunctionSep 8, 2026No Apparent Adverse Event
It was reported that there was no alleged issue at the time of intake. It was reported that there was no known patient impact.
Patient problems: Insufficient Information
MAUDE report 50662957 ↗MalfunctionSep 1, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50540037 ↗MalfunctionAug 25, 2026Difficult to Insert
It was reported that the cutter no longer locks in the attachment. There is no patient impact reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50429386 ↗MalfunctionAug 18, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50293187 ↗MalfunctionAug 14, 2026Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50250631 ↗MalfunctionAug 13, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237511 ↗MalfunctionAug 12, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50219422 ↗MalfunctionAug 7, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50171880 ↗MalfunctionAug 6, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50163924 ↗MalfunctionAug 5, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50138692 ↗MalfunctionAug 3, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114305 ↗MalfunctionAug 3, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112877 ↗MalfunctionAug 3, 2026Vibration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112293 ↗MalfunctionAug 3, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112110 ↗MalfunctionAug 3, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112109 ↗MalfunctionAug 3, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112107 ↗MalfunctionAug 3, 2026Loss of Power
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111944 ↗MalfunctionJul 31, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50095648 ↗MalfunctionJul 31, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50095617 ↗
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- RemB 6400015000Stryker Corporation · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE603 reports
- NA QD11Synthes GmbH · DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE580 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 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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