N/A 8225101 (UDI 20763000417028)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 20763000417028), received between Oct 17, 2022 and Apr 3, 2026 — classified as 2 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (30 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OPERATION, NIM 3.0 WAS NOISY, SHOWED IRREGULARITIES DURING MONITORING PROBABLY DUE TO INCORRECT DEVICE SETTING. USER REPLACED THE ELECTRODES AND THE STIMULATOR, RESTARTED THE DEVICE AND THE ISSUE RESOLVED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24773731 ↗
• MalfunctionFeb 20, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING TOTAL THYROIDECTOMY, THE DOCTOR STARTED USING THE PROBE AND EMG TUBE AND AT SOME POINT IT STOPPED WORKING. IT ALSO DID NOT EMIT ANY SOUND, THE EQUIPMENT WAS TURNED OFF AND TURNED ON AGAIN, IT STILL DID NOT EMIT SOUND AND THEN IT BEGAN TO SOUND WITH A LOUD BUZZING, IT WAS DECIDED TO TURN EVERYTHING OFF. SURGERY WAS PERFORMED WITHOUT THE USE OF THE NERVE MONITOR AND WITH THE REPORTED PROBE AND EMG TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398126 ↗
• MalfunctionFeb 11, 2026False Negative Result

  IT WAS REPORTED THAT DURING THE NERVE MONITORING PROCEDURE, THE PROBE HAD NO RESPONSE WHEN NERVE WAS TOUCHED. THE PROCEDURE WAS COMPLETED WITH BACK-UP DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311735 ↗
• MalfunctionJan 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE REQUIRED STIMULATION TIP DID NOT RECOGNIZE IN THE SYSTEM. THE EQUIPMENT WAS FULLY DISCONNECTED AND RECONNECTED, BUT THE TIP CONTINUED TO BE UNRECOGNIZED. CONSEQUENTLY, IT WAS NECESSARY TO PROVIDE A NEW STIMULATION TIP IN ORDER TO PROCEED WITH THE SURGERY WITHOUT INTERRUPTION. THE PROCEDURE WAS COMPLETED WITH THE BACK UP DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974009 ↗
• MalfunctionDec 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PROCEDURE, THE STIMULATOR PROBE WAS NON-FUNCTIONAL AND COULD NOT BE MADE TO WORK. THERE WAS A DELAY IN 5 TO 10 MINUTES IN THE SURGERY BECAUSE IT WAS IMPOSSIBLE TO STIMULATE THE NERVE DURING THE PROCEDURE, REQUIRING ANOTHER PROBE TO BE USED AFTER CHECKING THE CONNECTIONS AND PROCEDURE WAS COMPLETED, GENERAL ANESTHESIA WAS USED WITHOUT CURARE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894663 ↗
• MalfunctionDec 8, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OP, MONITORING FAILED DURING STIMULATION, IT WAS WORKING INTERMITTENTLY AND DID NOT SHOW SOUND SIGNALS CLEARLY. THE PROBE WAS USED AFTER OPENING FROM A SEALED PACKAGE. THE PROCEDURE WAS DELAYED BY 40 MINUTES AND WAS COMPLETED USING BACKUP PRODUCTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23739689 ↗
• MalfunctionNov 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PROCEDURE, THE PROBE DID NOT EMIT STIMULUS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567104 ↗
• MalfunctionOct 29, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT PROBE STIM DIDN'T WORK. WHEN ATTEMPTING TO STIMULATE THE NERVE, THE 'STIMULUS DELIVERY' TONE WAS HEARD, BUT IT DID NOT REPEAT IF THE SURGEON STIMULATED TOO RAPIDLY. NO WAVEFORM WAS DISPLAYED ON THE MONITOR DURING NERVE STIMULATION. NO MUSCLE RELAXANT WAS USED. THE PROCEDURE WAS COMPLETED WITH BACKUP PROBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415708 ↗
• MalfunctionOct 27, 2025False Negative Result; Inappropriate Audible Prompt/Feedback; False Negative Result; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING PROCEDURE THE INTUBATION TUBE IS INSERTED, A CHECK IS MADE TO ENSURE IT IS IN PLACE, AND THE STIMULATING PROBE IS PASSED TO THE INSTRUMENTATION UNIT AND CONNECTED TO THE INTERFACE. IT IS EVIDENT THAT THE EQUIPMENT IS CONSTANTLY MOVING IN WAVES, WITHOUT ACTUALLY STIMULATING. THE DOCTOR USES THE PROBE, BUT IT DOES NOT EMIT IMPULSES. EVERYTHING IS DISCONNECTED, AND THE PROBE DOES NOT WORK. USER CALLED THE SALES REPRESENTATIVE TO REQUEST A NEW PROBE, WHICH, UPON CONNECTION, BEGINS GENERATING IMPULSES CORRECTLY. MONITORING IS PERFORMED WITHOUT COMPLICATIONS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388160 ↗
• MalfunctionOct 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, A NERVE STIMULATOR WAS USED TO LOCATE THE FACIAL NERVE, BUT ONCE IT WAS FULLY IDENTIFIED AND VISUALIZED, THE STIMULATOR WAS USED, AND THE MONITOR DIDN'T REGISTER THE SIGNAL AS THE NERVE. THIS LED TO A REQUEST FOR ANOTHER STIMULATOR. WHEN USING THE NEW ONE, IT WAS ABLE TO STIMULATE THE NERVE, AND THE MONITOR REGISTERED IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372247 ↗
• MalfunctionSep 19, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT UPON STARTING THE PROCEDURE AND CHECKING THE ELECTRODES AND STIMULATOR, IT BECAME APPARENT THAT THE EQUIPMENT WAS GENERATING INTERFERENCE. THE INTERFERENCE GENERATED HAPPENED AFTER 20 MINUTES OF USE ON PATIENT WHEN STIMULATING THE NERVE. AFTER CHECKING THE CONNECTIONS, ENSURING THE ELECTRODES WERE CORRECTLY PLACED, AND VERIFYING THAT THE IMPEDANCE WAS ADEQUATE, IT WAS CONFIRMED THAT EVERYTHING WAS IN ORDER. AS THE PROBLEM PERSISTED, THE PROBE WAS REPLACED. ONCE THE REPLACEMENT WAS COMPLETED, IT WAS CONFIRMED THAT BOTH THE EQUIPMENT AND THE NEW PROBE WERE FUNCTIONING CORRECTLY. PATIENT STABLE, WITH NO NEW DEVELOPMENTS. MAPPING WAS PERFORMED AT THE END TO VERIFY THAT THE NERVES WERE PRESERVED, AND IT SHOWED GOOD PARAMETERS. NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23093006 ↗
• MalfunctionSep 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PROCEDURE, PROBE FAILED TO DISCHARGE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23013381 ↗
• MalfunctionSep 2, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OP, THE PROBE FAILED TO DISCHARGE, AND REPLACING THE PATIENT INTERFACE AND THE SOCKET DID NOT RESOLVE THE ISSUE. THERE WAS NO ANESTHESIA, MUSCLE RELAXANT ON BOARD, OR TOO MUCH FLUID IN THE FIELD WHICH COULD HAVE CAUSED A LACK OF RESPONSE. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE WHICH WAS OF THE SAME MODEL. IT WAS CONFIRMED THAT THE PATIENT INTERFACE WAS FUNCTIONING PROPERLY. AND ALL FOUR CHANNELS WERE INTACT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22931743 ↗
• MalfunctionJul 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OP, THERE WAS NO STIMULATION WITH THE PRASS PROBE. THE OUTPUT CURRENT REMAINED AT 0MA DESPITE CORRECT CONNECTION OF ALL LEADS AND VERIFICATION OF ELECTRODE CHECK. THE PROCEDURE WAS COMPLETED USING ANOTHER STIMULATION PROBE. THE PROBE WAS USED AFTER OPENING FROM A SEALED PACKAGE AND THERE WAS NO DAMAGE IN THE PACKAGING. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22434145 ↗
• MalfunctionMay 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Material Deformation; Incorrect, Inadequate or Imprecise Result or Readings; Material Deformation

  IT WAS REPORTED THAT INTRAOPERATIVE, THERE IS STIMULATION DETECTION PROBLEM WITH PROBE. DIFFICULTY FOR THE OPERATOR TO DETECT STIMULATION AS CHANGED APPEARANCE OF THE STIMULATOR (THE TIP OF THE STIMULATOR IS MORE ROUNDED THAN USUAL, MAKING IT DIFFICULT FOR THE OPERATOR TO DETECT STIMULATION). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111926 ↗
• MalfunctionMar 14, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING THE PAROTIDECTOMY PROCEDURE, THE NERVE MONITORING PROBE, WHEN THE DOCTOR USED IT TO DETECT NERVE, HE FOUND THERE WAS NO FUNCTION ON NIM. THE DOCTOR TRIED TO CHECK FUSE AND RECONNECT THE PROBE BUT USELESS. THERE WAS NO WAVEFORM APPEARED ON NIM. AND CURRENT STIM RETURN SHOWS "0". FINALLY, THE DOCTOR CHANGED A NEW PROBE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604367 ↗
• MalfunctionMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY, WHEN THE DOCTOR USED THE PROBE TO DETECT THE NERVE, NIM DIDN'T RESPOND UNTIL TWO SECONDS LATER. THE DOCTOR TRIED TO RECONNECT THE PROBE BUT USELESS. THE STIM RETURN SHOW 3 MA. AFTER 30 MINUTES, THE PROBE SUDDENLY WAS BACK TO NORMAL. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. NO DELAY IN THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592721 ↗
• MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING ENDOSCOPIC THYROID SURGERY, THERE WAS NO RESPONSE WHEN THE PROBE WAS INSERTED. SOMETIMES THERE WAS NO CURRENT DISPLAYED WHEN CONNECTED TO THE MACHINE. SOMETIMES IT SHOWS CURRENT PASSING, SOMETIMES IT SHOWS 0. WHEN THE DISPLAY WAS 0, THERE WAS NO SOUND OR IMAGE REMINDER. IN ORDER NOT TO AFFECT THE OPERATION, THE OPERATION WENT SMOOTHLY AFTER REPLACING A PROBE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21557278 ↗
• MalfunctionMar 6, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT INTRA OP, WHEN PERFORMING LEFT SUPERFICIAL PAROTIDECTOMY, WHEN SURGEON WANT TO STIMULATE, NO RETURN CURRENT AND SIGNAL AT THE MONITOR. THEY SUSPECTED THE FUSE WAS BLOWN AND REPLACED NEW FUSE BUT STILL NO RETURN CURRENT. IT WAS SUSPECTED THAT THE PROBE WAS FAULTY AND OPENED NEW PROBE. NOW RETURN CURRENT WAS PRESENT. THEY PERFORMED CONNECTIVITY TEST TO THE PROBE CABLE AND FOUND OUT THE WIRE CABLE DID NOT HAVE CONNECTIVITY. THEY SUSPECTED THE WIRE CABLE WAS FAULTY. THERE WAS A DELAY OF 20 MINUTES. THE PROCEDURE WAS COMPLETED USING BACKUP PRODUCTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536883 ↗
• MalfunctionMar 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PAROTIDECTOMY PROCEDURE, WHEN THE DOCTOR USED THE PROBE TO DETECT THE NERVE, IT WAS FOUND THAT THE STIM RETURNED SHOW 0MA. THE DOCTOR TRIED TO RECONNECT THE PROBE FROM STIM1 TO STIM2 BUT USELESS, FINALLY, THE DOCTOR CHANGED A PROBE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21499548 ↗
• MalfunctionMar 1, 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 FROM STIM1 TO STIM2 BUT USELESS, FINALLY, THE DOCTOR CHANGED A PROBE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21499546 ↗
• MalfunctionMar 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PAROTIDECTOMY PROCEDURE, WHEN THE DOCTOR USED THE PROBE TO DETECT THE NERVE, SHE FOUND THAT THE STIM RETURNED SHOW 0MA. THE DOCTOR TRIED TO RECONNECT THE PROBE FROM STIM1 TO STIM2 BUT USELESS, FINALLY, THE DOCTOR CHANGED A PROBE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21499540 ↗
• MalfunctionMar 1, 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, SHE FOUND THAT THE STIM RETURNED SHOW 0MA. THE DOCTOR TRIED TO CHANGE A FUSE OF PATIENT INTERFACE BUT USELESS, FINALLY, THE DOCTOR CHANGED A PROBE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21499504 ↗
• 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 21468906 ↗
• 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 21466754 ↗