N/A 8225101 (UDI 20763000040714)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20763000040714), received between Aug 10, 2022 and Mar 6, 2025 — classified as 7 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PROCEDURE THYROIDECTOMY WHEN THE DOCTOR USED THE PROBE TO DETECT THE NERVE, FOUND THAT THE STIM RETURNED SHOW 0MA. THE DOCTOR TRIED TO RECONNECT THE PROBE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW PROBE AND THE NEW PROBE COULD FUNCTION NORMALLY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21538016 ↗
• MalfunctionMar 5, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT THE DURING SUBTOTAL THYROIDECTOMY, WHEN THE DOCTOR USED THE PROBE TO DETECT NERVE, HE FOUND THAT THE PROBE HAS NO FUNCTION. CURRENT STIM RETURN SHOWS "0", INDICATING THAT CURRENT IS NOT BEING DELIVERED. THE DOCTOR CHECKED THE ELECTRODE CHECK AND FUSE IS NORMAL, SO THE DOCTOR THOUGHT THE PROBLEM IS PROBE. FINALLY, THE DOCTOR CHANGED A NEW PROBE TO COMPLETE THE SURGERY. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526498 ↗
• MalfunctionFeb 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, WHEN THE DOCTOR USED THE PROBE TO DETECT THE NERVE, HE FOUND THAT THE STIM RETURNED SHOW 0MA. THE DOCTOR TRIED TO RECONNECT THE PROBE BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW PROBE AND THE NEW PROBE COULD FUNCTION NORMALLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462235 ↗
• MalfunctionFeb 25, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, WHEN THE DOCTOR USED THE PROBE TO DETECT THE NERVE, FOUND THAT THE NIM DID NOT DISPLAY THE WAVEFORM. THE DOCTOR TRIED TO RECONNECT THE PROBE AND USED THE PATIENT SIMULATOR TO CHECK BUT USELESS. FINALLY, THE DOCTOR CHANGED A NEW PROBE AND THE NEW PROBE COULD FUNCTION NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461341 ↗
• MalfunctionSep 15, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHEN THE DOCTOR USED THE PROBE ABOUT 20 MINUTES, HE FOUND THE PROBE WAS NOT FUNCTIONING. THE DOCTOR TRIED TO REBOOT THE NIM AND RECONNECT THE PROBE BUT STILL NOT WORKING. FINALLY, THE DOCTOR CHANGED A NEW PROBE TO COMPLETE THE SURGERY. EVENT OCCURRED DURING THYROIDECTOMY PROCEDURE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432801 ↗
• MalfunctionSep 9, 2022Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE TIROIDECTOMIA BILATERAL SURGERY STARTED WITH THE RIGHT VOCAL CORD ELECTRODE WITH NO RESPONSE. IT MARKED X ON THE ELECTRODE CHECK. THE ENDOTRACHEAL TUBE WAS MOVED AND OBTAINED A SIGNAL. THEN, SURGEON STIMULATED DIRECTLY ON THE NERVE AND THE EQUIPMENT INDICATED THAT THERE WAS NO NERVE. SURGEON WAS SURE IT WAS IN THE NERVE, SO HAD A COMPETITOR PRODUCT BROUGHT IN, WHICH FINALLY GAVE AN ANSWER THAT IT WAS IN THE NERVE. THEY CONTINUED THE SURGERY WITH COMPETITOR PRODUCT. AT THE END, THE TUBE AND THE PROBE WAS REMOVED FROM THE SURGICAL FIELD, PERFORMED THE TESTS WITH THE PATIENT SIMULATOR AND EVERYTHING WAS RESPONDING CORRECTLY. THERE WAS NO PATIENT IMPACT. THERE WAS SURGICAL DELAY OF 60 MINUTES AND THERE WAS NO PRODUCT DAMAGE. PATIENT HAS MEDICAL HISTORY OF CA. DE TIROIDES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394688 ↗
• MalfunctionAug 10, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE PROBE DIDN¿T STIMULATE THE NERVE, THERE WAS NO RESPONSE RESULTING FROM ITS STIMULUS. NO ANY INTERVENTION PERFORMED. THERE WAS 10 MINUTES PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203890 ↗