N/A 8227410Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000034030), received between Jun 28, 2023 and Feb 2, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026False Negative Result

  IT WAS REPORTED THAT BEFORE USE, THERE WAS NO RESPONSE WHEN THE SURGEONS WERE TESTED. THE STIM RETURN ON THE MONITOR SHOWED 0, AND THERE WERE NO AUDIBLE INDICATORS OR ERROR MESSAGES REGARDING THE REPORTED ISSUE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE SURGEON COMPLETED THE PROCEDURE WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231395 ↗
• MalfunctionDec 28, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PRE OP SURGEON HAVE MENTIONED THE ELECTRODE NOT FUNCTIONING AFTER CONNECTED TO PATIENTS INTERFACE. NO READINGS AFTER TAPPING THE SKIN SIMULTANEOUSLY, THEY OPEN ANOTHER ELECTRODE TO PROCEED WITH THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904057 ↗
• MalfunctionDec 16, 2025False Negative Result; False Negative Result

  ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT IMPACT RELATED TO THE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818832 ↗
• MalfunctionSep 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PREOPERATIVELY, THE GROUNDING DID NOT RESPOND. THE GROUNDING RESPONSE COULD NOT BE CONFIRMED, ISSUE WAS RESOLVED BY REPLACING THE GROUNDING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080849 ↗
• MalfunctionApr 29, 2025False Negative Result; Inappropriate Audible Prompt/Feedback; False Negative Result; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING PAROTID PROCEDURE WHEN STIMULATING THE NERVE WITH 0.8, THERE WAS ONLY A BRIEF TONE. SURGEON COULD SEE THE NERVE TWITCHING WHEN STIMULATING, GOT THE TONE FOR NO NERVE, AND DID NOT SEE AN EMG ON THE SCREEN. DEFINITELY THE NERVE THAT GOT STIMULATED. WHILE PREFORMING A TAP TEST THE DEVICE DID WHAT IT WAS SUPPOSED TO DO AND ALSO SHOWING AN EMG AND DOING THE RIGHT NOISE. WHILE WORKING WITH THE PROBE, THERE WAS NO EMG SHOWN ON THE DISPLAY AND JUST THE BRIEF TONE. THERE WAS DELAY OF 45 MINUTES. THE THRESHOLD WAS SET DOWN TO 20. STILL NO CHANGE. PROCEDURE WAS COMPLETED WITH COMPETITOR NERVE MONITORING SYSTEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923812 ↗
• MalfunctionMar 13, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING PROCEDURE, THE RED WIRE OF THE ELECTRODE COULDN'T DETECT AND GENERATE SIGNAL. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21594044 ↗
• MalfunctionFeb 18, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PROCEDURE WITH THE CORRECT PROCEDURE THE ELECTRODE HAS NO SIGNAL AND SOMETIMES WAS NORMAL. AUDIO SOMETIMES IS NORMAL, IT WAS UNSTABLE. THE PROCEDURE WAS COMPLETED USING BACK UP PRODUCTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397768 ↗
• MalfunctionOct 1, 2024False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING COCHLEAR IMPLANT REMOVAL, FIELD CONTACT WAS REQUESTED TO COME TO THE OR. ONE CHANNEL WAS ON THE NIM VITAL WAS VERY REACTIVE AND REGISTERING EVENTS (WHILE THE PATIENT WAS NOT BEING TOUCHED) AND THE OTHER CHANNEL WAS NOT. TURNED EVENT CAPTURE OFF AND THE ACTIVE CHANNEL WAS ABOUT 100 UV AND OTHER ABOUT 7UV. PATIENT PUT INTO DEEPER SLEEP. ISSUE CONTINUED ON. SWITCHED FROM VITAL TO 3.0. SAME ISSUE PERSISTING. DOCTOR STATED THEY DO NOT WANT TO CHANGE ELECTRODES SINCE PATIENT ALREADY DRAPED. REPOSITIONING OF PATIENT WAS NOT ATTEMPTED. ELECTROCAUTERY WAS USED DURING THE PROCEDURE. THE NIM WAS POSITIONED ON THE OPPOSITE SIDE OF THE OR, IN A DIFFERENT OUTLET. NO ELECTRODES LAID ACROSS THE ELECTROCAUTERY WIRE FROM WHAT THE USER COULD SEE. PHYSICIAN ASSISTANT ANDFIELD REP SUSPECT BAD POTENTIALLY BAD ELECTRODES SINCE BOTH VITAL AND 3.0 GIVING SAME RESULTS. FIELD REP EXAMINED PLACEMENT OF ELECT RODES AND BELIEVED THEM TO BE POSITIONED WELL. NO NOTICEABLE DAMAGE TO ELECTRODES. FIELD CONTACT CONFIRMED PATIENT DOES NOT HAVE A PACEMAKER. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342330 ↗
• MalfunctionSep 20, 2024False Negative Result; False Positive Result; False Negative Result; False Positive Result

  IT WAS REPORTED THAT DURING PROCEDURE DOCTOR VISUALLY IDENTIFIED A NERVE. WHEN STIMULATED THE ASSOCIATE MUSCLE CONTRACTED HOWEVER THIS DID NOT REGISTER WITH THE NIM AS AN EVENT NOR MAKE A TWEEDLE OR THUD SOUND. OTHER AREAS WOULD REGISTER AS EVENTS ON THE NIM EXCEPT THE NERVE. DOCTOR SWITCHED NIM VITAL TO THE NIM 3.0, THE ISSUE PERSISTED, SO ELECTRODE WAS CHANGED AND THE ISSUE RESOLVED. PROCEDURE WAS EXTENDED BY FIVE MINUTES. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20269408 ↗
• MalfunctionSep 17, 2024False Negative Result; False Negative Result

  IT AS REPORTED THAT DURING A MASTOIDECTOMY CASE, THE SURGEON NOTICED INITIAL STIMULATION WHEN USING THE MONOPOLAR PROBE, BUT DID NOT HEARD ANY AUDITORY 'BEEPING' WHEN STIMULATING THE FACIAL NERVE. THE FACIAL NERVE WAS STILL UNDER BONE. BIOMEDICAL ENGINEERING TESTED THE CONSOLE AND PATIENT INTERFACE DURING THE PROCEDURE USING THE PATIENT SIMULATOR AND ANOTHER PROBE, AND THE SYSTEM TESTED NORMALLY. DURING THE PROCEDURE, THE SURGEON WAS STIMULATING AT 0.8MA, AND INCREASED TO 1.0MA AND TRIED TO RE-STIMULATE. NO RESPONSE, OTHER THAN SOMETHING FAINT, WAS NOTICED ON THE NIM-VITAL MONITOR. ELECTRODES WERE CHECKED TO ENSURE THEY WERE RESPONDING. ELECTRODE CHECK PERFORMED. NO RESPONSES ON MONITOR ABOVE EVENT THRESHOLD WERE ELICITED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20234012 ↗
• MalfunctionFeb 21, 2024Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING CANALPLASY SURGERY, ELECTRODE ON CHANNEL ONE WAS GIVING HIGH SIGNALS DURING SETUP REPLACED BLUE ELECTRODE ON CHANNEL 1 AND THIS ISSUE RESOLVED. THERE WAS A DELAY OF LESS THAN ONE HOUR IN SURGERY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18746238 ↗
• MalfunctionJun 28, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ELECTRODE WAS DEFECTIVE. THERE WAS NO KNOWN PATIENT IMPACT. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221414 ↗