NA TCN-15-3MRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813250017519), received between Sep 19, 2017 and Jul 16, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Defective Device” (5 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 29, 2026Open, Classified

   Reusable electrodes may not meet expected performance levels.

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

2. May 30, 2019Terminated

   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-1697-2020 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT HUB FELL OFF OF THE ELECTRODE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE DEVICE HAS BEEN RETURNED AND EVALUATED. THE ALLEGATION OF "NOT READING TEMPERATURE" WAS CONFIRMED. THE SHAFT OF THE ELECTRODE WAS SEVERED AT THE HUB AND NOT RETURNED FOR ANALYSIS. THE PROBABLE CAUSE SELECTED IS "UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT". THE SEVERED SHAFT WAS LIKELY DUE TO UNINTENDED EXCESSIVE EXTERNAL MECHANICAL FORCE.

  Patient problems: No Patient Involvement

  MAUDE report 10283447 ↗
• MalfunctionOct 15, 2019Defective Device; Defective Device

  A REPORT WAS RECEIVED THAT AN RF ELECTRODE BECAME DETACHED FROM THE HUB. THE ELECTRODE WILL BE SENT BACK FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 9192863 ↗
• MalfunctionOct 8, 2019Defective Device; Defective Device

  A REPORT WAS RECEIVED THAT AN ELECTRODE SNAPPED AT THE BASE OF THE HUB AND FELL OUT.

  Patient problems: No Patient Involvement

  MAUDE report 9169807 ↗
• MalfunctionOct 1, 2019Defective Device; Defective Device

  A REPORT WAS RECEIVED THAT THE ELECTRODE FELL OUT OF THE HUB.

  Patient problems: No Patient Involvement

  MAUDE report 9142380 ↗
• MalfunctionSep 10, 2019Defective Device; Defective Device

  A REPORT WAS RECEIVED THAT AN ELECTRODE BECAME SEPARATED FROM THE HUB.

  Patient problems: No Patient Involvement

  MAUDE report 8981178 ↗
• MalfunctionSep 19, 2017Material Discolored; Contamination /Decontamination Problem; Material Discolored; Contamination /Decontamination Problem

  DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODE SHOWED THAT THE EPOXY WAS DISCOLORED. 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 6877586 ↗