N/A 8225275Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000036096), received between Jun 23, 2022 and Dec 18, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT INTRA OP, AFTER CONNECTING THE EQUIPMENT, IT WAS DISCOVERED THAT THE PROBE WAS NOT RELEASING CURRENT AND HAD NO EFFECT WHEN PLACED ON THE NERVE. REPLACING THE PROBE WITH A NEW ONE RESOLVED THE ISSUE. THERE IS NO PATIENT IMPACT. THERE IS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836686 ↗
• MalfunctionNov 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE THYROIDECTOMY PROCEDURE, WHEN THE DOCTOR USED THE PROBE TO DETECT THE NERVE, HE FOUND THAT THE PROBE WOULD REACTION DELAY. THE DOCTOR TRIED TO RECONNECT THE PROBE BUT USELESS. THE STIM RETURNED SHOWS 3MA. THERE WERE NO VISUAL AND/OR AUDIBLE INDICATORS THAT ALERTED THE USER OF THE ISSUE. NO ERROR CODES ARE DISPLAYED. THE ISSUE WAS NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING. FINALLY, THE DOCTOR CHANGED A NEW PROBE TO COMPLETE THE SURGERY. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108245 ↗
• MalfunctionJul 14, 2023Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED DURING THYROIDECTOMY PROCEDURE, THAT WHEN THE DOCTOR USED THE PROBE FOR ABOUT 30 MINUTES, DOCTOR FOUND THAT THE NIM WOULD DELAY THE RESPONSE WHEN HE DETECT THE NERVE. AFTER USED THE PROBE FOR ABOUT 1.5 HOURS, THE DOCTOR FOUND THAT THE NIM HAD NO RESPONSE WHEN HE DETECT THE NERVE. SO, THE DOCTOR CHANGED A NEW PROBE AND THE NEW PROBE COULD FUNCTION NORMALLY. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. NO PATIENT IMPACT. NO PROCEDURE DELAY. ADDITIONAL INFORMATION RECEIVED, THE STIM RETURN WAS NOT SHOWING 0. THE ISSUE DISCOVERED AFTER USED ON A PATIENT. NO VISUAL OR AUDIBLE ALERTED THE USER OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17323568 ↗
• MalfunctionJun 23, 2022Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT DURING PROCEDURE AFTER BEING CONNECTED, THE PROBE DID NOT REACT. THE PROBE WAS SWITCHED OUT WITH BACKUP PRODUCT AND THE PROCEDURE WAS CARRIED OUT NORMALLY. DEVICE HAD CONTACT WITH PATIENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14792196 ↗