NIM Essence NIMEID080Recalls & reported problems
Medtronic Xomed, Inc. · ESSENCE EMG TUBE NIMEID080 5PK 8MM CE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000821814), received between Aug 7, 2026 and Aug 13, 2026 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (6 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert6
- Incorrect, Inadequate or Imprecise Result or Readings6
- Inappropriate Audible Prompt/Feedback1
Patient problems
- Insufficient Information4
- Unintended Extubation2
- Unspecified Tissue Injury2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Inappropriate Audible Prompt/Feedback
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50231734 ↗MalfunctionAug 11, 2026Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: Insufficient Information
MAUDE report 50204995 ↗MalfunctionAug 11, 2026Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: Insufficient Information
MAUDE report 50204972 ↗InjuryAug 8, 2026Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings
It was reported that Patient having the removal of a right hemi thyroid. The anesthetist used the Nim Essence tubes and spent over 30 minutes trying to intubate. The anesthetist had the Nim Vital on the setup electrode check screen and they said they spent all this time trying to achieve the green confirmation to proceed ticks, Every slight movement would mean that the ticks would go back to the red cross. So small adjustments slightly left then 5mm slight right to get the tube to be sat in the correct position and the electrode check kept changing from green ticks back to red ticks with no room for any slight error. They also re-intubated the patient with a second tube to have the same issue that only resolved when they used the Nim Flex tube. There was 30 min delay in the procedure. The patient suffered soft palet injury due to repeat re-intubation.
Patient problems: Unintended Extubation; Unspecified Tissue Injury
MAUDE report 50187129 ↗InjuryAug 8, 2026Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings
It was reported that Patient having the removal of a right hemi thyroid. The anesthetist used the Nim Essence tubes and spent over 30 minutes trying to intubate. The anesthetist had the Nim Vital on the setup electrode check screen and they said they spent all this time trying to achieve the green confirmation to proceed ticks, Every slight movement would mean that the ticks would go back to the red cross. So small adjustments slightly left then 5mm slight right to get the tube to be sat in the correct position and the electrode check kept changing from green ticks back to red ticks with no room for any slight error. They also re-intubated the patient with a second tube to have the same issue that only resolved when they used the Nim Flex tube. There was 30 min delay in the procedure. The patient suffered soft palet injury due to repeat re-intubation.
Patient problems: Unintended Extubation; Unspecified Tissue Injury
MAUDE report 50187128 ↗MalfunctionAug 7, 2026Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: Insufficient Information
MAUDE report 50171814 ↗MalfunctionAug 7, 2026Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: Insufficient Information
MAUDE report 50171153 ↗
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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 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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