N/A 8225103Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000417035), received between Feb 26, 2025 and Feb 26, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (2 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT A RIGHT THYROIDECTOMY WAS BEING PERFORMED BY DOCTOR. SHE STIMULATED THE RIGHT VAGUS NERVE. SURGEON COULD SEE AND FEEL MUSCLE TWITCH BUT THE NEGATIVE DWEEDLE WAS SHOWING ON THE NIM VITAL, NO WAVEFORM PRESENT. TURNED STIMULUS UP FROM 3.0 TO 7.0, GOT THE SAME RESPONSE. SWITCHED STIMULATING PROBES, SAME RESPONSE. SWITCHED TO A NIM 3.0, SAME RESPONSE. SHE WAS UNABLE TO GET THE NERVE TO SHOW ANY POSITIVE STIMULATION TONES OR WAVEFORM THROUGHOUT THE ENTIRE CASE. THRESHOLD WAS CHANGED THROUGHOUT THE CASE FROM 50-150. NIM VITAL WAS RUNNING 1.4.3 SOFTWARE .THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. THE PROCEDURE EXTENDED FOR FIFTEEN MINUTES. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468920 ↗
• MalfunctionFeb 26, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE VAGUS NERVE WAS STIMULATED AT 7.0 WITH NO NERVE RESPONSE ON THE MONITOR, DESPITE THE SURGEON VISUALIZING AND FEELING MUSCLE CONTRACTION. SIMILAR ISSUES OCCURRED WHEN STIMULATING THE LARYNGEAL NERVES, WHICH WERE VISUALLY CONFIRMED BUT DID NOT SHOW A NERVE RESPONSE WAVEFORM ON THE MONITOR. THE THRESHOLD WAS AT 150, AND RESPONSES WERE OCCASIONALLY OBSERVED. SWITCHING STIMULUS PROBES AND NIM VITAL SYSTEMS, AS WELL AS REPOSITIONING THE TUBE, DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT AND THERE WAS PROCEDURE DELAY OF 15 MINUTES. THE NIM STIMULUS SETTINGS WAS BETWEEN 1.0-7.0 MATCHING THE PRESENT STIMULUS VALUE AND CURRENT DELIVERY. THERE WAS NO MUSCLE RELAXANT WAS USED, AND DESPITE VISUAL LARYNGEAL TWITCH, THERE WERE NO POSITIVE VISUAL OR AUDIBLE INDICATORS ON THE NIM VITAL MONITOR. THE ISSUE PERSISTED DESPITE TROUBLESHOOTING, BUT NO UNANTICIPATED MEDICAL INTERVENTIONS WERE REQUIRED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466856 ↗