NA TCN-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00813250013061), received between Jun 5, 2017 and Jun 1, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (4 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 16, 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 · Recall details · 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-1696-2020 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE ELECTRODE WAS BROKEN AT THE HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916424 ↗
• MalfunctionAug 8, 2019Fluid/Blood Leak; Fluid/Blood Leak

  A REPORT WAS RECEIVED THAT THE FACILITY WAS UNABLE TO CLEAN 3 PROBES DUE TO THE HUB LEAKING AT THE BASE OF THE PROBE. THE FACILITY CLAIMS THAT IT WAS BLOOD LEAKING OUT OF THE HUB.

  Patient problems: No Patient Involvement

  MAUDE report 8876322 ↗
• MalfunctionAug 1, 2018Material Discolored; Fracture; Material Discolored; Fracture

  DEVICE ANALYSIS WAS PERFORMED ON THE RETURNED ELECTRODE. THE ELECTRODE PASSED THE FUNCTIONAL TEST HOWEVER A VISUAL INSPECTION REVEALED DISCOLORED EPOXY. 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. THIS FAILURE MECHANISM IS UNRELATED TO THE REPORTED COMPLAINT AND IS DUE TO THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7740421 ↗
• MalfunctionOct 2, 2017Leak/Splash; Leak/Splash

  THE RETURNED ELECTRODE VISUAL INSPECTION REVEALED TRACES OF POTTING EPOXY ON THE HUB. THE EPOXY LEAKED THROUGH THE SHAFT OPENING IN ITS LIQUID STATE DURING THE MANUFACTURING PROCESS, AND WAS NOT REMOVED AFTER CURING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6908612 ↗
• MalfunctionSep 11, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  THE DEVICE ANALYSIS PERFORMED SHOWED THAT THE EPOXY HAS CHIP OUT AND DISCOLORATION. 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 6854680 ↗
• MalfunctionAug 25, 2017Break; Break

  DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODE REVEALED THAT THE SHAFT WAS BROKEN OFF FROM THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6820888 ↗
• MalfunctionAug 11, 2017Material Discolored; Material Erosion; Material Discolored; Material Erosion

  DEVICE ANALYSIS PERFORMED ON ALL THE RETURNED ELECTRODES SHOWED THAT THE EPOXY WAS CHIPPED OUT AND DISCOLORED DUE TO THERMAL STRESS ASSOCIATED WITH AUTOCLAVE CYCLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6788910 ↗
• MalfunctionJun 20, 2017Break; Material Discolored; Material Separation; Break; Material Discolored; Material Separation

  A REPORT WAS RECEIVED THAT THE PLASTIC ON THE ELECTRODE WAS BREAKING OFF AND COMING APART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6654512 ↗
• MalfunctionJun 6, 2017Material Separation; Material Separation

  A REPORT WAS RECEIVED THAT AN ELECTRODE WAS NOT REACHING TEMPERATURE. DEVICE ANALYSIS SHOWED THAT THE ELECTRODE SHAFT WAS BROKEN AT THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6614592 ↗
• MalfunctionJun 5, 2017Material Separation; Material Separation

  A REPORT WAS RECEIVED THAT AN ELECTRODE WAS NOT COMING UP TO TEMPERATURE. DEVICE ANALYSIS CONFIRMED THROUGH VISUAL INSPECTION THAT THE ELECTRODE STILL WORKED BUT HAD A LOOSE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6612500 ↗