NA 8225101Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 20681490176686), received between Sep 15, 2017 and Mar 10, 2025 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (7 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE, WHEN THE DOCTOR USED THE PROBE TO DETECT NERVE, THE NIM DOESN'T SHOW THE WAVEFORM. SO, THE DOCTOR USED PATIENT SIMULATOR TO CHECK NIM SYSTEM AND IT COULD FUNCTION NORMALLY, BUT NOT SURE THE PROBLEM WAS PROBE OR ENDOTRACHEAL TUBE. THE STIM RETURN SHOW 3 MA. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561545 ↗
• MalfunctionFeb 26, 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, HE FOUND THE STIM RETURN SHOWED 0MA. THE DOCTOR TRIED TO RECONNECT THE PROBE BUT IT DOES NOT WORKED. FINALLY, THE DOCTOR CHANGED A PROBE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471706 ↗
• MalfunctionFeb 26, 2025Erratic or Intermittent Display; No Device Output; Erratic or Intermittent Display; No Device Output

  IT WAS REPORTED THAT PRE-OP, THE PROBE HAD NO SIGNAL AND IT WAS GLIMMERING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466204 ↗
• MalfunctionFeb 26, 2025Erratic or Intermittent Display; No Device Output; Erratic or Intermittent Display; No Device Output

  IT WAS REPORTED THAT PRE-OP, THE PROBE HAD NO SIGNAL AND IT WAS GLIMMERING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21466184 ↗
• MalfunctionFeb 25, 2025Erratic or Intermittent Display; No Device Output; Erratic or Intermittent Display; No Device Output

  IT WAS REPORTED THAT PRE-OP, THE PROBE HAD NO SIGNAL AND IT WAS GLIMMERING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462358 ↗
• MalfunctionOct 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A TRIVANTAGE ENDOTRACHEAL TUBE, WHICH IS DELIVERED BY INDICATION OF ANESTHESIOLOGIST, TUBE LUBRICATED WITH LIDOCAINE IN SPRAY, ELECTRODE ENDS ARE CONNECTED IN INTERFACE ALONG WITH GROUND ELECTRODES WHICH ARE PLACED BY THE RESIDENT PHYSICIAN IN THE DELTOID ON THE LEFT SIDE OF THE PATIENT, TAKING INTO ACCOUNT THAT THE NEEDLES DO NOT COME INTO CONTACT WITH EACH OTHER, WE PROCEED TO VERIFY THAT DURING THE ELECTRODE CHECK ALL ARE FOUND GREEN, WE PROCEED TO CONNECT A MONOPOLAR STIMULATOR, DURING ASEPSIS OF THE SURGICAL AREA PERFORMS THE TAP TEST WITH A GOOD RESPONSE. AFTER MAKING THE INCISION IN THE NECK ON THE RIGHT SIDE, SURGEON INDICATES THAT HE WILL STIMULATE FOR THE FIRST TIME, KEEPING THE VAGUS NERVE IN SIGHT, SO THE IMPULSE IS RAISED TO 2.0MA, VOLUME 50% AND THRESHOLD AT 100, HAVING NO AMPLITUDE RESPONSE OR LATENCY, ONLY THE SOUND RESPONSE OF NO NERVE AVAILABLE, THEY CONTINUE WITH THE SURGERY, STIMULATING AGAIN UNDER THE SAME PARAMETERS WITHOUT RESPONSE, AFTER THE THIRD ATTEMPT AND NO RESPONSE WE CHANGE PARAMETERS TO 2.5MA AND THRESHOLD TO 70 TO PERFORM THE NEXT STIMULATION, AGAIN WITH NO RESPONSE OF NERVE, HAVING THE IMMEDIATE RESPONSE FROM THE DOCTOR THAT HE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17874864 ↗
• MalfunctionJul 8, 2022False Positive Result; False Positive Result

  THE DISTRIBUTOR REPORTED THAT DURING THYROIDECTOMY SURGERY DEVICES HAD A LOT OF UN-STIMULATED (MECHANICAL) EVENT ON NIM, AND IT AFFECT THE DETECTION OF NERVE. THE DOCTOR TRIED TO REBOOT THE NIM, RECONNECT THE PROBE AND ELECTRODE, USED THE PATIENT SIMULATOR TO CHECK NIM BUT USELESS. FINALLY, THE DOCTOR COMPLETE THE SURGERY WITHOUT CHANGED THE ENDOTRACHEAL TUBE AND PROBE. NO PATIENT IMPACT, PROCEDURE DELAY AND INTERVENTION PERFORMED. THE PROCEDURE COMPLETED WITH THE REPORTED DEVICES. ON FOLLOW-UP NORMAL MONITORING WAS CONTINUED NO ISSUES EVEN IF THERE IS A NOISE, ISSUE DOES NOT RESOLVED WITH REPOSITIONING. THE PROCEDURE COMPLETED WITH THE REPORTED DEVICE. ELECTROSURGICAL EQUIPMENT WAS USED BUT NOT USED AT THE TIME OF STIMULUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960832 ↗
• MalfunctionNov 19, 2020Failure to Sense; Failure to Sense

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PRODUCT WAS FINE AT THE PRE-TEST BUT THE DEVICE CANNOT WORK DURING THYROIDECTOMY, THE PROBE COULDN'T GIVE ANY RESPONSE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10866484 ↗
• MalfunctionApr 14, 2020Unable to Obtain Readings; Unable to Obtain Readings

  ON FOLLOW-UP, IT WAS REPORTED THAT THERE WERE NO ERROR CODES DISPLAYED OR ANY VISUAL/AUDIBLE INDICATOR THAT ALERTED THE USER OF THE ISSUE. THE ISSUE WAS NOT RESOLVED BY REPOSITIONING OR TROUBLESHOOTING. IT WAS NOTED THAT IT WAS THE INITIAL USE OF THE ELECTRODE AND PROBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9956204 ↗
• MalfunctionMar 30, 2020Sensing Intermittently; Device Sensing Problem; Sensing Intermittently; Device Sensing Problem

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT WHEN THE DOCTOR USED THE PROBE DURING A PAROTIDECTOMY PROCEDURE, HE FOUND THAT DETECTION WAS NOT SENSITIVE. SOMETIMES THERE WAS A RESPONSE AND SOMETIMES THERE WAS NO RESPONSE. AFTER SEVERAL TESTS, IT DID NOT IMPROVE. THERE WAS A DELAY OF 5 MINUTES IN THE PROCEDURE AS A RESULT OF THIS EVENT. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. THE PATIENT WAS ALIVE WITH NO INJURY. ON FOLLOW-UP, IT WAS REPORTED THAT THERE WAS NO VISUAL AND/OR AUDIBLE INDICATORS THAT ALERTED THE USER OF THE ISSUE. THE DOCTOR JUDGED THAT THE DEVICE WAS MALFUNCTIONING. THE CURRENT STIM RETURN VALUE DISPLAYED WAS NOT "0", FOR TROUBLESHOOTING, THE DOCTOR TRIED TO RECONNECT THE PROBE AND RESTART THE NERVE MONITOR BUT BOTH WERE USELESS. ON FOLLOW-UP, IT WAS REPORTED THAT DETECTION OF INSENSITIVITY IMPROVED AFTER THE DOCTOR CHANGED THE PROBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897739 ↗
• MalfunctionFeb 25, 2020Sensing Intermittently; Sensing Intermittently

  ADDITIONAL INFORMATION RECEIVED MENTIONED THAT THE STIM RETURN WAS NOT 0 AND THERE WAS NO VISUAL OR AUDIBLE INDICATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9749555 ↗
• MalfunctionOct 14, 2019Use of Device Problem; Use of Device Problem

  A HEALTHCARE PROVIDER REPORTED THAT THE PROBE DID NOT WORK AT ALL. ANOTHER PROBE WAS OPENED AND IT WAS FINE. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9186347 ↗
• MalfunctionFeb 20, 2019Unable to Obtain Readings; Unable to Obtain Readings

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT AFTER ABOUT 30 MINUTES INTO THE SURGERY, THE DOCTOR NOTICED THAT THE PROBE COULD NOT DETECT NERVES. THERE WAS NO REACTION AND NO ELECTRODE RETURN. NO ERROR CODE WAS DISPLAYED ON THE MONITOR. THE DOCTOR CHECKED THE CONNECTIONS OF THE PROBE AND OTHER ELECTRODES, ALL THE CONNECTIONS WERE FIRM. AS A RESULT, THE DOCTOR REPLACED THE PROBE WITH ANOTHER NEW PROBE. THE SECOND PROBE COULD FUNCTION PROPERLY WITH THE SAME SYSTEM. IT WAS THE INITIAL USE OF THE PROBE. THE PROCEDURE WAS A THYROIDECTOMY. THE SURGERY WAS DELAYED FOR ABOUT 3 MINUTES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8353682 ↗
• MalfunctionJan 17, 2019Failure to Sense; Failure to Sense

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT IN THE MOST BEGINNING OF THE THYROID SURGERY, THE PROBE COULD NOT DETECT NERVES. THERE WAS NO REACTION AND NO ERROR CODE ON THE MONITOR. THE DOCTOR CHECKED ALL THE CONNECTIONS BUT COULD NOT SOLVE THE PROBLEM. THEREFORE, THE HCP TRIED ANOTHER NEW PROBE. THE NEW PROBE COULD FUNCTION PROPERLY WITH THE SAME MONITOR. THE SURGERY WAS DELAYED FOR ABOUT 3 MINUTES. THE DOCTOR SAID IT WAS THE INITIAL USE OF THE PROBE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8257522 ↗
• MalfunctionDec 14, 2018Failure to Sense; Failure to Sense

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT A NERVE MONITORING DEVICE WAS NOT SENSING THE SIGNAL DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8165578 ↗
• MalfunctionNov 20, 2018Use of Device Problem; Device Sensing Problem; Use of Device Problem; Device Sensing Problem

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A DISTRIBUTOR THAT THE PROBE DID NOT FUNCTION STEADILY AFTER ABOUT AN HOUR DURING A THYROIDECTOMY PROCEDURE. A WARNING SOUND WAS HEARD BUT OTHER TIMES THERE WOULD BE NO SIGNAL. THERE WAS NO ERROR CODE DISPLAYED ON THE MONITOR. THE DOCTOR RECONNECTED ALL THE CONNECTIONS BUT THE ISSUE PERSISTED. THE DOCTOR CHANGED THE PROBE AND THE ISSUE WAS NOT RESOLVED. THE DOCTOR CHANGED THE ENDOTRACHEAL TUBE AND THE SYSTEM FUNCTIONED PROPERLY. THE PROCEDURE WAS DELAYED FOR 12 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE SECOND SET OF PROBE AND ENDOTRACHEAL TUBE.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 8088569 ↗
• MalfunctionNov 19, 2018Failure to Sense; Failure to Sense

  A HEALTH CARE PROFESSIONAL (HCP) REPORTED VIA DISTRIBUTER THAT THE PROBE WAS NOT TRANSMITTING STIMULATION DURING THE PROCEDURE. ANOTHER PROBE WAS USED AND WORKED NORMALLY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8086332 ↗
• MalfunctionAug 15, 2018Unable to Obtain Readings; Unable to Obtain Readings

  A HEALTHCARE PROFESSIONAL REPORTED THAT THEY WERE NOT GETTING READINGS OCCASIONALLY WHEN WIGGLING THE CABLE AND THE SECOND PROBE WOULD WORK ONLY WHEN HOLDING THE TIP AT 90 DEGREES TO THE SIMULATOR. THE TIP WAS BENT ON THE SECOND PROBE. THE DEVICE WAS TESTED WITH ORIGINAL PROBE AND TEST PROBE. THE ORIGINAL PROBE WOULDN¿T RESPOND OCCASIONALLY. THE DEVICE WAS TESTED WITH AN ELECTRODE CHECK AND ALL PROBES TESTED 0.6 KOHMS. WENT TO MONITOR MODE AND TESTED WITH BIOMED PROBE. ALL FOR CHANNELS ON SIM ONE AND SIM TWO GAVE AROUND 150 UV READING ON SCREEN. THEY CONFIRMED THE ISSUE WAS WITH PROBE AND NOT THE UNIT. IT WAS NOTED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787494 ↗
• MalfunctionAug 13, 2018Intermittent Continuity; Intermittent Continuity

  USING THE STIMULATING PROBE, THE DOCTOR WAS NOT GETTING READINGS OCCASIONALLY; THE NIM UNIT WAS TESTED WITH A NEW, DIFFERENT PROBE WITHOUT ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7778384 ↗
• MalfunctionJul 25, 2018Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem

  A CUSTOMER REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT CURRENT DIDN¿T COME OUT FROM THE PROBE. THE SURGEON USED ANOTHER NEW ONE INSTEAD. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 7718593 ↗
• MalfunctionJul 11, 2018Failure to Sense; Appropriate Device Problem Term/Code Not Available; Failure to Sense

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT THE PROBE WAS FUNCTIONING PROPERLY AT THE BEGINNING OF A PAROTID SURGERY. HOWEVER, THE DOCTOR NOTICED THE PROBE COULD NOT DETECT NERVES DURING THE OPERATION. THE DOCTOR CHECK ALL THE CONNECTIONS BUT COULDN'T FIX THE PROBLEM, BUT WHEN THEY TRIED A NEW PROBE IT FUNCTIONED PROPERLY. IT WAS THE INITIAL USE OF THE PROBE AND THE SURGERY WAS DELAYED FOR LESS THAN 3 MINUTES. IT WAS NOTED THAT THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7680080 ↗
• MalfunctionJul 11, 2018Device Sensing Problem; Appropriate Device Problem Term/Code Not Available; Device Sensing Problem

  THE CUSTOMER REPORTED WHEN USING THE PROBE IT WAS WORKING INTERMITTENTLY. THEY HAD TO DISCONNECT AND RECONNECT TO MAKE IT WORK.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7678675 ↗
• MalfunctionJul 3, 2018Failure to Sense; Failure to Sense

  A DISTRIBUTOR REPORTED THAT THE PROBE WAS FUNCTIONING PROPERLY AT THE BEGINNING OF THE SURGERY. THE PROBE WAS UNABLE TO DETECT NERVES AFTER ABOUT 30 MINUTES INTO THE SURGERY. THERE WAS NO WARNING SOUND WHEN THE PROBE WAS NEAR NERVES. THE DOCTOR RECONNECTED THE PROBE BUT THE PROBLEM WAS NOT RESOLVED. THE DOCTOR THEN SWITCHED TO A NEW PROBE AND THE ISSUE RESOLVED. THE THYROID SURGERY WAS DELAYED FOR ABOUT 5 MINUTES. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7660926 ↗
• MalfunctionJun 4, 2018Failure to Sense; Failure to Sense

  A DISTRIBUTOR REPORTED THAT THE PROBE COULD NOT DETECT NERVES. THERE WAS NO SIGNAL WHEN THE PROBE CONTACTED NERVES AND NO ERROR CODE WAS SHOWN ON THE MONITOR. THE PROBLEM WAS NOTICED AT THE VERY BEGINNING OF A THYROIDECTOMY. THE DOCTOR CHECKED ALL THE CONNECTIONS AND RECONNECTED THE PROBE BUT THE PROBE STILL COULD NOT DETECT NERVES. THE ISSUE WAS RESOLVED WHEN A NEW PROBE WAS USED. THE SURGERY WAS DELAYED FOR ABOUT 5 MINUTES. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7567956 ↗
• MalfunctionFeb 26, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION INDICATED THAT THE THAT THE STIM RETURN CABLE WAS PLUGGED INTO THE WRONG PORT (STIM 2) AND THIS IS WHY THIS PROBLEM OCCURRED. THE NIM WAS SET AT 1.0, DEVICE HAD WAVE FORMS FROM USUAL MANIPULATION (LITTLE BLIPS), GREEN TICKS WERE OBTAINED; WHITE LINE PRESENT. THE PROBE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7298527 ↗