NIM Trivantage® 8229707 (UDI 00643169782594)Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 00643169782594), received between Jul 28, 2017 and Dec 12, 2025 — classified as 13 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (57 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K112686); they may or may not involve this specific model.

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.

Recalls naming this device

1. Nov 7, 2023Open, Classified

   Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,

   Z-0696-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE THYROID PROCEDURE, THE CUSTOMER RECEIVED INTERMITTENT EMG INTERFERENCE. THE CUSTOMER STATES THAT THEY WERE NOT STIMULATING A NERVE AND NO ERROR MESSAGE WAS PRESENT ON THE SCREEN. AFTER TROUBLE SHOOTING THEY BELIEVE THAT IT WAS THE TUBE PLACEMENT. TRIED 2 DIFFERENT PI BOXES WITH SAME RESULTS. WHEN THEY DID ELECTRODE CHECK ON BOTH PI BOXES IT WAS CYCLING BETWEEN GREEN CHECKS AND RED X. TS RECOMMENDED ENSURING THE SITE IS NOT USING ELECTROCAUTERY AND ENSURE UNIT IS PLUGGED INTO A RED OUTLET WITH NO OTHER SYSTEMS PLUGGED INTO THE OUTLET. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787274 ↗
• MalfunctionJul 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  ADDITIONAL INFORMATION RECEIVED THAT, THE ISSUE PERSISTED AFTER IT WAS SHUT DOWN AND RESTARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552209 ↗
• MalfunctionJul 16, 2025False Positive Result; False Positive Result

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING INTRA-OPERATION IT WAS REPORTED USING A STIM OF 1.0, THE SYSTEM WAS NOT PASSING ELECTRODE CHECK WITH AN X ON VOCALIS 1 THEN WOULD PASS 30 SECONDS LATER. CHANNEL 1 WOULD VERY SHARP SPIKES THAT WERE WAY ABOVE THRESHOLD. ABLE TO GET RESPONSES FROM THE NERVE EVEN WITH THE ISSUES WITH CHANNEL 1. SURGERY HAS BEEN EXTENDED LESS THAN ONE HOUR. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520271 ↗
• MalfunctionJul 16, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING THYROID LOBECTOMY PROCEDURE, AFTER INTUBATING THE EMG TUBE INTO THE PATIENT, THE TUBE CONTINUED TO HAVE A LOT OF ARTIFACT IN THE MIDDLE OF THE CASE AND WERE ABLE TO CONTINUE THE CASE AND STILL MONITOR. THE PROCEDURE EXTENDED LESS THAN 1 HOUR. THERE WERE NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520151 ↗
• MalfunctionJul 16, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT INTRA-OP, THAT WHILE USING THE NIM VITAL FOR A THYROIDECTOMY CASE, THE CHANNEL IN WHICH THE TRIVANTAGE TUBE WAS CONNECTED TO WAS MAKING EXCESSIVE NOISE. THEY TRIED SWAPPING TO A NIM 3.0, NOISES CONTINUES. EVENTUALLY, THEY HAVE SWAPPED OUT TO A DIFFERENT TRIVANTAGE TUBE AND CONTINUED WITH THE CASE OF SAME SIZE AND CONTINUED WITH SURGERY WITH THE NIM 3.0. THERE WAS NO EXCESSIVE NOISE THEN. THERE WAS SURGICAL DELAY OF LESS THAN 1 HOUR. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 22519819 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT THERE WAS NOISY NIM VITAL DURING THYROID SURGERY, GOOD ELECTRODE CHECK. SWITCHED TO NIM 3.0, FAILED ELECTRODE CHECK ON ONE CHANNEL, STILL NOISY. SUSPECT ISSUE WITH TRIVANTAGE TUBE. NO DELAY IN CASE. THERE IS NO ALLEGATION AGAINST NIM 3.0 AND NIM VITAL. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519329 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THREE CONSECUTIVE 7.0MM TRIVANTAGE TUBES WERE INTRODUCED INTO THE PATIENT'S TRACHEA BECAUSE NO ELECTRODE CHECK SEEMED TO PASS. ACCORDING TO THE ANESTHESIOLOGIST, THE MAXIMAL TUBE SIZE WAS USED FOR THE PATIENT, AND THE PATIENT WAS NOT UNDER ANESTHETICS AT THE TIME OF INTUBATION. ALSO, NO LUBRICANT WAS USED ON THE EXTERNAL WALLS OF THE TUBE. THE NIM 3.0 NEURO WAS ALSO REBOOTED MULTIPLE TIMES DURING THE PROCEDURE, AND ELECTRODES RE-INSERTED INTO THE PATIENT INTERFACE WITHOUT IT HAVING ANY IMPACT ON THE ELECTRODE CHECK. THE PROCEDURE EXTENDED FOR ONE HOUR. THYROIDECTOMY WAS PERFORMED WITHOUT MONITORING, WITHOUT ANY PATIENT HARM. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518244 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THREE CONSECUTIVE 7.0MM TRIVANTAGE TUBES WERE INTRODUCED INTO THE PATIENT'S TRACHEA BECAUSE NO ELECTRODE CHECK SEEMED TO PASS. ACCORDING TO THE ANESTHESIOLOGIST, THE MAXIMAL TUBE SIZE WAS USED FOR THE PATIENT, AND THE PATIENT WAS NOT UNDER ANESTHETICS AT THE TIME OF INTUBATION. ALSO, NO LUBRICANT WAS USED ON THE EXTERNAL WALLS OF THE TUBE. THE NIM 3.0 NEURO WAS ALSO REBOOTED MULTIPLE TIMES DURING THE PROCEDURE, AND ELECTRODES RE-INSERTED INTO THE PATIENT INTERFACE WITHOUT IT HAVING ANY IMPACT ON THE ELECTRODE CHECK. THE PROCEDURE EXTENDED FOR ONE HOUR.THYROIDECTOMY WAS PERFORMED WITHOUT MONITORING, WITHOUT ANY PATIENT HARM. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518229 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING TOTAL THYROIDECTOMY BOTH ELECTRODES WERE MAKING NOISE AND THEN EVENTUALLY TURNED OFF. ELECTRODE CHECK WAS NOT PASSING SO PATIENT WAS RE-INTUBATED WITH A NEW TUBE (SAME LOT NUMBER). SITE COULD NOT GET THE ELECTRODE CHECK TO PASS. ENT REP. TRIED REPOWERING THE NIM VITAL TWO DIFFERENT TIMES, REPOWERED THE PI BOX TWICE, TRIED THE PI BOX BOTH WIRED AND WIRELESS. EVENTUALLY TRIED HOOKING UP THE PATIENT SIMULATOR AND EVERYTHING CONNECTED AND ELECTRODE CHECK PASSED. PROCEDURE WAS COMPLETED WITHOUT A NERVE MONITOR. PROCEDURE DELAYED BY 5 MINUTES. NO PATIENT INJURY. LATER NIM VITAL WAS BEING USED IN ANOTHER PROCEDURE (THYROIDECTOMY) AND THE NIM MONITOR AND TUBE WERE ALL WORKING PROPERLY AS INTENDED WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517906 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING TOTAL THYROIDECTOMY BOTH ELECTRODES WERE MAKING NOISE AND THEN EVENTUALLY TURNED OFF. ELECTRODE CHECK WAS NOT PASSING SO PATIENT WAS RE-INTUBATED WITH A NEW TUBE (SAME LOT NUMBER). SITE COULD NOT GET THE ELECTRODE CHECK TO PASS. ENT REP. TRIED REPOWERING THE NIM VITAL TWO DIFFERENT TIMES, REPOWERED THE PI BOX TWICE, TRIED THE PI BOX BOTH WIRED AND WIRELESS. EVENTUALLY TRIED HOOKING UP THE PATIENT SIMULATOR AND EVERYTHING CONNECTED AND ELECTRODE CHECK PASSED. PROCEDURE WAS COMPLETED WITHOUT A NERVE MONITOR. PROCEDURE DELAYED BY 5 MINUTES. NO PATIENT INJURY. LATER NIM VITAL WAS BEING USED IN ANOTHER PROCEDURE (THYROIDECTOMY) AND THE NIM MONITOR AND TUBE WERE ALL WORKING PROPERLY AS INTENDED WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 22517680 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING FULL THYROIDECTOMY TUBE AND UPDATED 1.4.3 NIM VITAL WERE USED. A BITE BLOCK WAS ALSO USED.  AT THE START OF THE CASE ALL CHANNELS WERE GREEN CHECKS. ALL ELECTRODE PORTS WE SECURING IN THE PI BOX.  CHANNEL TWO (PATIENT RIGHT SIDE) WAVEFORMS WENT VERY SPORADIC AND THEN ¿LEAD ELECTRODE OFF¿ ¿PLEASE CHECK ELECTRODES¿. AFTER AN HOUR OR SO CHANNEL 2 WOULD NOT GIVE A GREEN CHECK MARK. IN ORDER TO CONTINUE WITH THE CASE WE HAD TO MAKE CHANNEL TWO INACTIVE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517223 ↗
• MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Component Missing; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate Audible Prompt/Feedback; Component Missing

  IT WAS REPORTED THAT THE RIGHT CHANNEL WAS CONSTANTLY REACTING THROUGHOUT THE CASE 35,000MVS. THEY MUTED THE CHANNEL SO THE SOUND FROM THE MACHINE WOULD NOT ANNOY THE SURGEON WHILE DOING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THE 2ND CASE RESPONDED EXACTLY LIKE THE FIRST. VERY HIGH IMPEDANCE. THE SECOND PROCEDURE WAS COMPLETED WITH THE SAME PRODUCT WITHOUT INJURY TO THE PATIENT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517115 ↗
• MalfunctionJul 16, 2025False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROIDECTOMY PROCEDURE THE SITE EXPERIENCED EXCESSIVE NOISE FROM CHANNEL 1. THIS WAS NOT EXPERIENCED UNTIL ABOUT 3 HOURS INTO THE CASE. UPON RUNNING AN ELECTRODE CHECK, CHANNEL 2 WAS INTERMITTENTLY FAILING AND PASSING. UPON REMOVING THE TUBE, USER NOTED THE TUBE TO BE SLIGHTLY BENT. THE PROCEDURE WAS COMPLETED BY REPORTED DEVICES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516946 ↗
• MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PROCEDURE ONE OF THE LEADS OF EMG TUBE WAS NOT RECOGNIZED BY THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479328 ↗
• MalfunctionJul 11, 2025False Positive Result; Intermittent Communication Failure; False Positive Result; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING PAPILLARY CANCER - TOTAL THYROIDECTOMY WITH RADICAL NECK DISSECTION, IMMEDIATELY AFTER THE PATIENT WAS STERILE DRAPED AND PREPPED, THE LEFT/BLUE ELECTRODE ON THE TUBE STARTED MAKING EXTRA NOISE. (LARGE RESPONSES IN THE 500-100UV). WE WERE ALREADY USING A BITE BLOCK (SOFT GAUZE ROLL) AND TRIED ADJUSTING THE TUBE IN DIFFERENT LOCATIONS WITHIN THE MOUTH TO ELIMINATE THE EXTRA NOISE. THE PATIENT WAS NOT GETTING LIGHT - EVENT CAPTURE OFF READINGS WERE BETWEEN 5-19UV. WE DID ANOTHER ELECTRODE CHECK AND THE BLUE CHANNEL WOULD ONLY PASS (GREEN) INTERMITTENTLY AND GO RED AT OTHER TIMES. ABOUT 1 HOUR INTO THE CASE, THE RED CHANNEL STARTED GIVING LARGE RESPONSES AND THE ELECTRODE CHECK WOULD ONLY PASS INTERMITTENTLY ON THIS CHANNEL. I HAD ANESTHESIA TRY ADJUSTING THE TRIVANTAGE TUBE POSITION AGAIN TO ENSURE IT WASN'T BEING PULLED TIGHTLY AGAINST TEETH. NOTHING HELPED - THE SURGEON ALSO NOTICED THAT THE LARYNX WOULD SUDDENLY START TWITCHING SPONTANEOUSLY (NO STIMULATION BEING USED) . I ASKED THE SURGEON TO TRY STIMULATING IN DIFFERENT AREAS OF THE THYROID TISSUE AND MUSCLE. EVERYWHERE SHE TOUCHED WOULD GIVE A POSITIVE EMG RESPONSE (4 PULSES PER SEC WITH AMPLITUDE CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478122 ↗
• MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THYROID PROCEDURE, THE BLUE ELECTRODE/CHANNEL ON THE NIM VITAL SYSTEM WAS GOING CRAZY. USER REFUSED TO USE A BITE BLOCK WITH THE TUBE. TECHNICIAN INSTRUCTED, ELECTRODE CHECK AND THAT SAME BLUE CHANNEL WOULD ONLY INTERMITTENTLY PASS THE ELECTRODE CHECK (RED, GREEN, RED). USER REFUSED TO TRY ADDING THE BITE BLOCK THEN THEY COULD JUST MUTE THAT CHANNEL AND STILL RECEIVE A POSITIVE EMG RESPONSE WHEN STIMULATING ON THE LEFT/BLUE THROUGH THE RED CHANNEL AS LONG ITS ABOVE 100 THRESHOLD. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478084 ↗
• MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING PROCEDURE, AFTER INTUBATING THE PATIENT, THE ELECTRODES WERE CONNECTED TO THE INTERFACE OF THE PATIENT, CHECKED BUT NIM 3.0 DID NOT RECOGNIZE, REPOSITIONED THE TUBE VARIOUS TIMES WITHOUT SUCCESS. TESTED THE EQUIPMENT WITH THE SIMULATOR AND IT WORKED NORMALLY. RECONNECTED TO TUBE AND REMAINED UNRESPONSIVE. THE SURGERY WAS EXTENDED BY 2 HOURS. THE SURGERY WAS COMPLETED WITHOUT MONITORING. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478077 ↗
• MalfunctionJul 11, 2025Inappropriate Audible Prompt/Feedback; Connection Problem; Inappropriate Audible Prompt/Feedback; Connection Problem

  IT WAS REPORTED BY THE HCP THAT DURING INTRA-OP, SURGEON WAS PERFORMING A NECK DISSECTION WITH LARYNGEAL NERVE MONITORING ALONG WITH SURFACE ELECTRODES IN CHANNEL 3 AND 4. SITE CALLED TO SAY NIM VITAL WAS VERY LOUD ON CHANNELS 1 AND 2 (VOCALIS 1 AND 2). SALES REP DID AN ELECTRODE CHECK ON THE SYSTEM AND NO CONNECTION FROM CHANNELS 1 AND 2. EMG TUBE WAS PLUGGED IN PROPERLY TO THE PATIENT INTERFACE. CHANNELS 3 AND 4 WORKED FINE. AFTER CASE SWITCHED THE TRIVANTAGE ELECTRODES TO CHANNELS 3 AND 4 AND STILL RECEIVED NO CONNECTION ON THE EMG CHECK. HOOKED UP THE PATIENT INTERFACE TO THE PATIENT SIMULATOR AND ALL CONNECTIONS RECEIVED GREEN CHECK MARKS. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCT. AFTER EXTUBATING THE PATIENT, THE NURSE IN THE ROOM CUT THE EMG PLUG IN LEADS FROM THE TUBE. THEY ARE INCLUDED IN THE BIOHAZARD BAG. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478014 ↗
• MalfunctionJul 11, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING PROCEDURE THE TUBE WAS PLACED IN ACCORDANCE WITH IFU. WHEN THE NERVE MONITOR WAS PLACED INTO "MONITOR" MODE CONSTANT AUDIBLE AND EMG WAVE FORMS BEGAN. TROUBLESHOOTING WAS PERFORMED INCLUDING SWAPPING OUT THE NIM 3.0 CONSOLE FOR A DIFFERENT NIM 3.0 CONSOLE. THE ISSUE PERSISTED UNTIL ULTIMATELY THE TUBE WAS REPLACED. THE PROCEDURE EXTENDED FOR 30 MINUTES. THERE WERE NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22478003 ↗
• MalfunctionJul 11, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THE TUBE LOST CONNECTIVITY WITH NIM AND REPLACED WITH ANOTHER TUBE, IT WORKED FINE. PROCEDURE GOT EXTENDED BY 10 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 22477968 ↗
• MalfunctionJul 11, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT DURING THYROIDECTOMY WITH NIM VITAL NERVE MONITORING, A LOT OF NOISY ARTIFACTS WERE PRESENT THROUGHOUT THE CASE ON BOTH SIDES/ELECTRODES. CHANGED PI BOXES, AND CHECKED FOR ELECTRICAL INTERFERENCE, REPOSITIONED THE TUBE, AND PERFORMED AN ELECTRODE CHECK. THE PROCEDURE WAS EXTENDED TO 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE REPORTED PRODUCTS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477950 ↗
• MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BEFORE THE CASE EMG TUBE WAS INSERTED IN THE PATIENTS THROAT, ELECTRODE CHECK SHOWED THAT ALL VOCALIS WAS A GREEN LIGHT. AS THE CASE PROGRESSED, VOCALIS 1 WAS SHOWING MASSIVE VALUES OF MICROVOLTS AND THEN AN ERROR MESSAGE OF "LEAD OFF" WAS READ ON THE SCREEN. REP. CALLED I.T. AND WENT THROUGH ALL THE TROUBLE SHOOTING FOR THE NIM VITAL. FINISHED THE CASE AND REMOVED THE TUBE TO BE SENT IN FOR INSPECTION. NO PATIENT IMPACT. PATIENT WAS INTUBATED FOR THIS PROCEDURE; THERE WAS NO PATIENT IMPACT DURING THE PROCEDURE. THE CASE WAS COMPLETED WITH THE ALLEGED TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477852 ↗
• MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT INTRA-OP, AT ABOUT HALFWAY THROUGH THE THYROIDECTOMY PROCEDURE, THE NIM WIRES WERE PLUGGED INTO THE HANDPIECE T O PERFORM AN ELECTRODE CHECK. VOCALIS 1 FAILED THE ELECTRODE CHECK. CIRCULATOR MADE SURE WIRES WERE PLUGGED COMPLETELY INTO THE HANDPIECE AND A NEW HANDPIECE WAS ALSO TRIED WITH THE SAME RESULTS. THE DEFECTIVE TUBE WAS REPLACED WITH ANOTHER NIM TRIVANTAGE TUBE. NO KNOWN PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 22477800 ↗
• MalfunctionJul 11, 2025Inappropriate Audible Prompt/Feedback; Inappropriate Audible Prompt/Feedback

  IT WAS REPORTED THAT DURING INTRA OP THEY WERE HAVING AN ISSUE WITH THE EMG TUBE BEING VERY NOISY, LOTS OF CONSTANT EVENTS. THE PROCEDURE HAS COMPLETED WITH NO PROBLEM AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477780 ↗
• MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT , DURING THE THYROIDECTOMY PROCEDURE WITH MONITORING OF THE RECURRENT LARYNGEAL N., DURING THE INTUBATION AND PLACEMENT OF THE MONITORING TUBE, THERE ARE TECHNICAL FAILURES IN THE VERIFICATION OF THE ELECTRODES, WHERE ONE OF THE VOWELS IS NOT RECOGNIZED, THE TUBE IS RE-ARRANGED, POSSIBLE FAILURES IN THE SURGICAL FIELD ARE REVIEWED, SUCH AS ELECTRICAL INTERFERENCE AND IT CONTINUES TO SHOW FAILURES AT THE TIME OF CHECKING THE ELECTRODES WITHOUT OBTAINING A POSITIVE RESPONSE. THE TUBE IS REMOVED AND A NEW ELECTROMYOGRAPHY TUBE IS PLACED WITH A REFERENCE. DIFFERENT AND DIFFERENT BATCH TO SOLVE THE PROBLEM PRESENTED. THE EVENT WAS RESOLVED BY REPLACING IT WITH ANOTHER HOMOLOGOUS DEVICE AND BEING ABLE TO PROCEED WITH THE SCHEDULED PROCEDURE. THE TRIVANTAGE ENDOTRACHEAL TUBE SHOWED THE FAILURES WHEN CHECKING THE ELECTRODES JUST AT THE TIME OF INTUBATION OF THE PATIENT BEFORE STARTING THE PROCEDURE AND IT SHOWS THAT THERE IS NO CONTACT BETWEEN ONE OF THE ELECTRODES WITH THE VOCAL CORD, FOR WHICH ALL PERTINENT MEASURES ARE TAKEN TO CORRECT THE FAILURE BUT NO POSITIVE RESPONSE IS OBTAINED TO THE EVENT THAT OCCURRED, FOR WHICH THE DEVICE IS REMOVED AND REPLACED BY ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477768 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112686. One submission often covers many models, so check the product and lot details in each record.

• Z-0743-2022 · Dec 22, 2021 · Open, Classified
  NIM TRIVANTAGE EMG Endotracheal Tube
• Z-1420-2013 · Mar 4, 2013 · Terminated
  REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonville, FL 32216-0980 USA STERILE Rx Only