NA TCN-10-3MRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00813250017502), received between Aug 18, 2017 and May 5, 2022 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (7 reports).

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

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.

Recalls naming this device

1. Apr 29, 2026Class IIOpen, Classified

   Reusable electrodes may not meet expected performance levels.

   Z-2403-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 30, 2019Class IITerminated

   The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.

   Z-1695-2020 · Root cause: Error in labeling · Recall details · FDA record ↗

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.

• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BLOOD SEEPED INTO WHERE THE PROBE ATTACHES TO THE STAINLESS HEAD OF THE ELECTRODE. THE BLOOD COULD NOT BE REMOVED AND KEPT SEEPING OUT DESPITE ATTEMPTS OF STERILIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14289701 ↗
• MalfunctionOct 22, 2019Insufficient Heating; Defective Device; Insufficient Heating; Defective Device

  THE DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODE REVEALED THAT THE SHAFT OF THE ELECTRODE WAS FOUND TO BE COMPLETELY SEPARATED FROM THE HUB.

  Patient problems: No Patient Involvement

  MAUDE report 9219134 ↗
• MalfunctionAug 9, 2018Material Discolored; Material Discolored

  THE DEVICE ANALYSIS PERFORMED ON THE ELECTRODE REVEALED THAT IT HAD DISCOLORED EPOXY AND A CHIP OUT. THE COLOR OF THE NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES IT BECOMES BRITTLE AND DISCOLORED. THIS FAILURE MECHANISM IS UNRELATED TO THE REPORTED COMPLAINT AND IS DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7770233 ↗
• MalfunctionOct 3, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODES SHOWED THAT THE EPOXY HAD A CHIP OUT AND DISCOLORATION WAS NOTED. THE COLOR OF NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES, IT BECOMES BRITTLE AND DISCOLORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6911523 ↗
• MalfunctionSep 14, 2017Break; Material Discolored; Break; Material Discolored

  DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODES FOUND THAT THE EPOXY HAD A CHIP OUT AND WAS ALSO DISCOLORED. THE COLOR OF NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES IT BECOMES BRITTLE AND DISCOLORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6864449 ↗
• MalfunctionSep 8, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  THE DEVICE ANALYSIS PERFORMED SHOWED THAT THE EPOXY HAS CHIP OUT AND BROWN DISCOLORATION. IN ADDITION, THE ELECTRODE FAILED THE TEMPERATURE TEST AS IT READS NO TEMPERATURE. IT HAD A DEFECTIVE THERMOCOUPLE CIRCUIT. THE OPEN CIRCUIT WAS MEASURED AT THE CONNECTOR. THE COLOR OF NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES, THE EPOXY BECOMES BRITTLE AND DISCOLORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6853580 ↗
• MalfunctionAug 29, 2017Material Discolored; Material Discolored

  DEVICE ANALYSIS PERFORMED SHOWED THAT BOTH ELECTRODES HAVE DISCOLORED AND CHIPPED OUT EPOXY. THE COLOR OF NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES, THE EPOXY BECOMES BRITTLE AND DISCOLORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6828412 ↗
• MalfunctionAug 24, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  DEVICE EVALUATION FOR THE RETURNED ELECTRODES REVEALED THAT THE EPOXY WAS DISCOLORED AND HAD A CHIP OUT. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES THE EPOXY BECOMES BRITTLE AND DISCOLORED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6819185 ↗
• MalfunctionAug 18, 2017Material Discolored; Material Discolored

  DEVICE ANALYSIS ON THREE ELECTRODES CONFIRMED THAT THE EPOXY WAS VERY DARK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6803513 ↗