NA 5140-508-240Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327177329), received between Aug 27, 2019 and Aug 27, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE THE MONITOR WAS BEEPING DUE TO INTERFERENCES DURING ELECTROCAUTERY, LASTING FOR A FEW MOMENTS AFTER CAUTERY HAD STOPPED. THIS CONDITION, IN WHICH THE DEVICE IS DELIVERING ADDITIONAL AUDIBLE INDICATION, MAY BE MISUNDERSTOOD BY THE USER, POSING INCREASED RISK OF NERVE INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934562 ↗
• MalfunctionAug 27, 2019Noise, Audible; Noise, Audible

  DURING A PROCEDURE IN WHICH THE MONITOR WAS IN USE WITH A MUTE SENSOR, IT WAS REPORTED THAT THERE WAS NOT ENOUGH AUDIO FEEDBACK BEING MUTED. THIS CONDITION, IN WHICH THE DEVICE IS DELIVERING ADDITIONAL AUDIBLE INDICATION, MAY BE MISUNDERSTOOD BY THE USER, POSING INCREASED RISK OF NERVE INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934560 ↗
• MalfunctionAug 27, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER THE USE OF ELECTROCAUTERY, THERE WAS ADDITIONAL, INCONSISTENT BEEPING FROM THE MONITOR. THIS CONDITION, IN WHICH THE DEVICE IS DELIVERING ADDITIONAL AUDIBLE INDICATION, MAY BE MISUNDERSTOOD BY THE USER, POSING INCREASED RISK OF NERVE INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934550 ↗
• MalfunctionAug 27, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING A TYMPANOMASTOIDECTOMY PROCEDURE, THE MONITOR WAS BEEPING AFTER THE USE OF ELECTROCAUTERY. THIS CONDITION, IN WHICH THE DEVICE IS DELIVERING ADDITIONAL AUDIBLE INDICATION, MAY BE MISUNDERSTOOD BY THE USER, POSING INCREASED RISK OF NERVE INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934549 ↗
• MalfunctionAug 27, 2019Failure to Sense; Device Displays Incorrect Message; Noise, Audible; Failure to Sense; Device Displays Incorrect Message; Noise, Audible

  IT WAS REPORTED THAT WHILE ELECTROCAUTERY WAS IN USE DURING A PROCEDURE, THE MONITOR WAS EXCESSIVELY BEEPING, DISPLAYED A DIALOG BOX ON THE SCREEN WHEN THE STIMULATION PROBE WAS NOT IN USE, AND HAD AN INTERMITTENT LOSS OF RECORDING CHANNEL, WHICH WOULD RETURN WHEN ELECTROCAUTERY ENDED. THESE CONDITIONS, IN WHICH THE DEVICE IS DELIVERING ADDITIONAL AUDIBLE INDICATION OR HAS AN INACCURATE VISIBLE DISPLAY, MAY BE MISUNDERSTOOD BY THE USER, POSING INCREASED RISK OF NERVE INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934548 ↗
• MalfunctionAug 27, 2019No Device Output; Use of Device Problem; No Device Output; Use of Device Problem

  IT WAS REPORTED THAT DURING USE IN A PROCEDURE, THE MONITOR WAS NOT PROVIDING AUDITORY INDICATION, BECAUSE A USER HAD ACCIDENTLY BUMPED A CONTROL KNOB AND TURNED OFF THE STIMULATION ENERGY. THIS CONDITION, IN WHICH THE DEVICE DOES NOT DELIVERY ENERGY, MAY BE INTERPRETED BY THE USER AS A FALSE NEGATIVE RESULT, POSING INCREASED RISK OF NERVE INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934534 ↗
• MalfunctionAug 27, 2019Failure to Sense; Noise, Audible; Failure to Sense; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, THE MONITOR EXPERIENCED A LOSS OF THE NERVE CONFIRMATION TONE, PROVIDING ONLY ARTIFACT NOISE. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF NERVE INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934533 ↗