NIM 8225825XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20763000112459), received between May 1, 2024 and Apr 13, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (3 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA OPERATIVELY, THAT THE INCREMENTING PROBE IS NOT FUNCTIONING. THE PROBE WAS STILL STIMULATING AND THEY WERE STILL RECEIVING POSITIVE NERVE CONFIRMATION HOWEVER, THE INCREMENTING PORTION WAS NOT FUNCTIONING. THE PROBE GAVE READINGS OF 1.0. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859783 ↗
• MalfunctionNov 4, 2025False Negative Result; False Negative Result

  ADDITONAL INFORMATION RECEIVED THAT NO ELECTROSURGICAL EQUIPMENT WAS USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460935 ↗
• MalfunctionJan 6, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT INTRA OP, EXCESSIVE ARTIFACTS BEING PICKED UP BY THE NIM, SO THE SURGEON REQUESTED FOR A SECOND ONE TO BE OPENED, WHICH WORKED FINE. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077404 ↗
• InjuryMay 6, 2024False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE TOTAL THYROID FOR GRAVES DISEASE AND GOITER, STARTED THE PROCEDURE ON LEFT SIDE LOBECTOMY, NIMS TUBE FOR INTUBATION AND MONITORING FOR PROCEDURE. UNIT SETUP AND TESTED AT PROCEDURE BEGINNING, AND RECEIVING FEEDBACK DURING BEGINNING OF PROCEDURE. LATER IN THE PROCEDURE, THE SURGEON STATED "NIMS WAS NOT WORKING". AT THAT TIME, IT WAS ON THE MONITORING SCREEN, WITH NO ERRORS OR MESSAGES, AND PROVIDING NO FEEDBACK. RESTARTED THE UNIT AND HARDWIRED THE PATIENT INTERFACE WITH THE UNIT. AT THIS POINT IT HAD INTERMITTENT "LOST CONNECTION" MESSAGES. CONNECTIONS WERE DOUBLE CHECKED AND THEN MOVED TO RIGHT SIDE AND ALL WORKED FINE. AT PROCEDURE END, SURGEON STATED COMPLICATION OF PROCEDURE WAS TRANSECTED NERVE. THERE WAS A BLOOD LOSS ABOUT 500ML. THE PATIENT COULD SWALLOW BUT HIS VOICE IS BREATHY; UPON FOLLOW-UP THE PATIENT WAS HOARSE, AND VOICE HAD NOT RECOVERED SEVERAL DAYS LATER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Nerve Damage

  MAUDE report 19249239 ↗
• MalfunctionMay 1, 2024False Negative Result; Inappropriate Audible Prompt/Feedback; False Negative Result; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING PAROTID CASE, THE SURGEON HAD A NEGATIVE TONE (TWEEDLE) WHEN TOUCHING A NERVE. PHYSICIAN EXPECTED TO HEAR THE POSITIVE ¿BUMP BUMP BUMP¿ BIPHASIC WAVE SOUND INDICATING THE NERVE WAS BEING STIMULATED. INSTEAD, THE TWEEDLE INDICATING THAT THEY WERE NOT TOUCHING NERVE RESPONDED. PHYSICIAN WAS CONFIDENT HE WAS ON NERVE. OLDER PHYSICIAN THAT WAS TRAINED WITHOUT THE NIM AND VERY STRONG ANATOMY KNOWLEDGE. FELT STRONGLY THAT THE SYSTEM WAS INCORRECT. THE PROCEDURE WAS EXTENDED FOR LESS THAN 1 HOUR. THERE WAS NO PATIENT IMPACT. EVENT COULD NOT BE REPLICATED BY REP OR BIOMED. USED SUBSEQUENTLY WITH DIFFERENT PI BOX AND WORKED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219366 ↗