N/A 8227411Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000034047), received between Sep 9, 2022 and Apr 1, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026False Negative Result

  IT WAS REPORTED THAT BEFORE USE, THE ELECTRODE WAS UNABLE TO SENSE. THEY HAVE TRIED RECONNECTING, AND STILL THE ISSUE PERSISTS. THE PROCEDURE WAS COMPLETED BY RECONNECTING THE PROBE TO THE PATIENT INTERFACE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750930 ↗
• MalfunctionMar 3, 2026False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT PRE-OP, THE NURSE ON SITE FOUND THAT THERE WAS A PROBLEM WHEN UNPACKING, THE PRODUCT COULD NOT BE ROTATED AND COULD NOT BE USED PROPERLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW DEVICE. THE EVENT DID NOT INVOLVE ANY PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493904 ↗
• MalfunctionAug 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED DURING PRE-OP THAT THE DEVICE HAD CONNECTING THE ELECTRODE TO THE PATIENT AND THE DEVICE, IT WAS FOUND THAT AFTER THE ELECTRODE WAS CONNECTED TO THE PATIENT, THE DEVICE SHOWED THAT THE CONNECTION WAS NOT SUCCESSFUL. PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCTS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22696879 ↗
• MalfunctionJun 17, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BLUE ELECTRODE FOUND TO BE UNRESPONSIVE. IT DID NOT RESPOND AT ALL AND HAD TO BE REPLACED WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22217634 ↗
• MalfunctionMar 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING COCHLEAR IMPLANT PROCEDURE WHEN THE DOCTOR USED THE PROBE TO DETECT NERVE AND THE STIM RETURN SHOWED 1.5MA, BUT FOUND THERE WAS NO WAVEFORM ON NIM. THE DOCTOR TRIED TO CHECK STIM RETURN, FUSE AND ELECTRODE CHECK AND ALL OF THE ABOVE WERE NORMAL. SO, THE DOCTOR THOUGHT THE PROBLEM WAS PAIRED SUBDERMAL ELECTRODES. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21603373 ↗
• MalfunctionMar 6, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT DURING TYMPANIC MASTOIDECTOMY PROCEDURE, AFTER THE TOUCH TEST CARRIED OUT BY BOTH THE TECHNICIAN AND THE DOCTOR THE SET OF ELECTRODES FAILED TO COMMUNICATE WITH NIM MAINFRAME. STIM RETURN SHOWED "0" INDICATING THAT THERE WAS NO CURRENT BEING DELIVERED AND NO WAVEFORM DISPLAYED. A NEW SET OF ELECTRODES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY AND NO INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535355 ↗
• MalfunctionOct 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem; Incorrect, Inadequate or Imprecise Result or Readings; Connection Problem

  IT WAS REPORTED THAT DURING THE SURGERY, THE SUBCUTANEOUS ELECTRODE COULD NOT BE USED NORMALLY AND IT WAS NOT RECOGNIZED BY THE CONSOLE. ONE SET OF SUBCUTANEOUS ELECTRODE WAS REPLACED, BUT IT STILL COULDN'T BE RECOGNIZED. A THIRD SET OF SUBCUTANEOUS ELECTRODE WAS REPLACED AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903359 ↗
• MalfunctionMar 15, 2023Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT ELECTRODE CANNOT BE DETECTED. EVENT OCCURRED INTRA OPERATIVE. THERE IS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542729 ↗
• 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 15394902 ↗