NA 5140-530-856Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 07613327292183), received between Nov 5, 2018 and Aug 27, 2019 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (40 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934567 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 CLINICALLY SIGNIFICANT SURGICAL DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8934558 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934553 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934552 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934551 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934547 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934546 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934545 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934542 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934541 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934540 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934539 ↗
• MalfunctionAug 27, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. 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 8934537 ↗
• MalfunctionJul 12, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. 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 8786675 ↗
• MalfunctionJul 2, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. 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 8754753 ↗
• MalfunctionJun 20, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. 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 8716511 ↗
• MalfunctionJun 20, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. 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 8716506 ↗
• MalfunctionJun 6, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. 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 8674483 ↗
• MalfunctionJun 6, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. 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 8674478 ↗
• MalfunctionJun 4, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. 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 8668162 ↗
• MalfunctionMay 31, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658457 ↗
• MalfunctionMay 31, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658456 ↗
• MalfunctionMay 31, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8658375 ↗
• MalfunctionMay 30, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655381 ↗
• MalfunctionMay 30, 2019Failure to Sense; Failure to Sense

  IT WAS REPORTED THE DEVICE HAD A LOSS OF SIGNAL DURING A SURGICAL PROCEDURE AT THE USER FACILITY. THIS CONDITION, IN WHICH THE ELECTRICAL CIRCUIT IS INCOMPLETE, MAY RESULT IN THE LOSS OF NERVE MONITORING RECORDING FUNCTION, POSING INCREASED RISK OF TRANSECTION OF A NERVE. 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 8653607 ↗