NA 8227411 (UDI 00643169290013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169290013), received between Jun 15, 2018 and Apr 14, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 9956197 ↗
• MalfunctionApr 26, 2019Failure to Sense; Failure to Sense

  A HEALTH CARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REPORTED THAT THERE WAS NO EMG RESPONSE AFTER STIMULATION, THE ELECTRODE HAD DIFFICULTY IDENTIFYING THE NERVE DURING THE PROCEDURE. THERE WAS NO KNOWN PATIENT IMPACT.

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

  MAUDE report 8558062 ↗
• MalfunctionJan 14, 2019Unable to Obtain Readings; Unable to Obtain Readings

  A HEALTH CARE PROVIDER (HCP) REPORTED VIA A DISTRIBUTOR THAT AFTER ALL THE ELECTRODES WERE SET FOR A PAROTIDECTOMY PROCEDURE, THE DOCTOR CONFIRMED THAT ALL ELECTRODES ON THE MONITOR WERE CHECKED. HOWEVER, WHEN THE DOCTOR DID FURTHER TESTING BY PATTING THE PATIENT'S FACE, HE FOUND THAT THERE WAS NO REACTION FROM THE NERVES OF CHIN, THE PURPLE ELECTRODE. THE DOCTOR TRIED TO RESET THE ELECTRODE AND CHECKED ALL THE CONNECTIONS, HOWEVER THERE WAS STILL NO REACTION. FINALLY, THE DOCTOR USED A DIFFERENT PURPLE ELECTRODE TO COMPLETE THE SURGERY. THE SECOND PURPLE ELECTRODE COULD FUNCTION PROPERLY WITH THE SAME MAINFRAME. THERE WAS NO ERROR CODE DISPLAYED ON THE MONITOR. THE HCP NOTED THAT IT WAS THE INITIAL USE OF THE ELECTRODE. THE PROBLEM WAS NOTICED DURING TESTING, THEREFORE THERE WAS NO STIM VALUE SINCE THE DOCTOR HAD NOT USED THE PROBE WHEN THE PROBLEM WAS NOTICED. THE SURGERY WAS DELAYED FOR ABOUT 10 MINUTES. THERE WAS NO PATIENT IMPACT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245807 ↗
• MalfunctionJun 15, 2018Failure to Sense; Low impedance; Failure to Sense; Low impedance

  A DISTRIBUTOR REPORTED THAT THE DEVICE HAD A SHORT CIRCUIT DURING THE OPERATION AND THE NERVE COULD NOT BE TESTED DURING THE OPERATION BUT WAS ABLE TO BE USED AFTER THE REPLACEMENT. 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 7605867 ↗