MAUDE Adverse Event Report: Medtronic Xomed Inc. ESSENCE EMG TUBE NIMEID080 5PK 8MM CE; STIMULATOR, NERVE

Model Number	NIMEID080
Medical Device Problem Codes	Difficult to Insert (1316); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Unintended Extubation (4564)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ESSENCE EMG TUBE NIMEID080 5PK 8MM CE
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): Medtronic Xomed Inc.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): Medtronic Xomed Inc.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; +1(763)526-5677
• MDR Report Key: 50187129
• Report Number: 1045254-2026-01107
• Device Sequence Number: 10081318
• Product Code: ETN
• UDI-Device Identifier: 00763000821814
• UDI-Public: (01)00763000821814(17)280905(10)2025090036
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K251672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NIMEID080
• Device Catalogue Number: NIMEID080
• Device Lot Number: 2025090036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/08/2026
• Date Device Manufactured: 09/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female