NA TCN-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00813250013054), received between Jun 6, 2017 and Oct 6, 2023 — classified as 2 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (34 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-1694-2020 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BURN LINE AT THE RIGHT HIP WHERE THE ELECTRODE WAS SET. THIS WAS CONFIRMED A USER ERROR BY THE PHYSICIAN. BASED ON THE INVESTIGATION, THE PHYSICIAN WAS USING 5 NEEDLES USING THE 4 ELECTRODES. THE PHYSICIAN PLACED THE ELECTRODE ONTO THE SIDE OF THE PATIENT IN WHICH NORMALLY IS NOT WHAT THE PHYSICIAN DOES. THE PHYSICIAN USED THE 5TH NEEDLE ON THE WRONG ELECTRODE INSIDE THE PATIENT. THE ELECTRODE THAT WAS ON THE SIDE OF THE PATIENT SHOULD HAVE BEEN THE ONE USED FOR THE 5TH NEEDLE. THIS IS WHAT CAUSED THE PATIENT INJURY BURN.

  Patient problems: Burn(s)

  MAUDE report 17892497 ↗
• MalfunctionAug 17, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE PROBE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568606 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT THAT IS ENROLLED IN THE A4087 RAPID CLINICAL STUDY EXPERIENCED A MIGRAINE THAT WAS MODERATE IN SEVERITY. THE PATIENT WAS PRESCRIBED MEDICATION AND THE EVENT RESOLVED THE NEXT DAY. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE DEVICE, HOWEVER THERE ARE NO IMPLANTED DEVICES. THE PATIENT UNDERWENT TWO SEPARATE RADIOFREQUENCY PROCEDURES, THE FIRST ON (B)(6) 2022 IN THE MID/LOW BACK REGION AND THE SECOND ON (B)(6) 2022 TO THE RIGHT SIDE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN BELIEVES THAT THE PATIENT'S HEADACHE MAY HAVE BEEN CAUSED BY IRRITATION OF THE CERVICAL AREA.

  Patient problems: Headache

  MAUDE report 16721807 ↗
• 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 11916863 ↗
• MalfunctionJul 17, 2019Material Discolored; Material Discolored

  A REPORT WAS RECEIVED THAT AN ELECTRODE WAS FOUND TO HAVE RESIDUAL BLOOD LEFT INSIDE THE PROBE WHERE THE WIRE CONNECTS AFTER MULTIPLE USES. THE RESIDUAL BLOOD WAS NOTICED AFTER BEING CLEANED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798718 ↗
• MalfunctionJul 17, 2019Material Discolored; Material Discolored

  A REPORT WAS RECEIVED THAT AN ELECTRODE WAS FOUND TO HAVE RESIDUAL BLOOD LEFT INSIDE THE PROBE WHERE THE WIRE CONNECTS AFTER MULTIPLE USES. THE RESIDUAL BLOOD WAS NOTICED AFTER BEING CLEANED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798685 ↗
• MalfunctionJul 17, 2019Material Discolored; Material Discolored

  A REPORT WAS RECEIVED THAT AN ELECTRODE WAS FOUND TO HAVE RESIDUAL BLOOD LEFT INSIDE THE PROBE WHERE THE WIRE CONNECTS AFTER MULTIPLE USES. THE RESIDUAL BLOOD WAS NOTICED AFTER BEING CLEANED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798632 ↗
• MalfunctionJun 19, 2019Defective Device; Defective Device

  A REPORT WAS RECEIVED THAT THE HUB SEPARATED FROM THE ELECTRODE WHILE IT WAS BEING WASHED.

  Patient problems: No Patient Involvement

  MAUDE report 8713822 ↗
• MalfunctionMay 7, 2019Material Fragmentation; Material Fragmentation

  DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODE REVEALED THAT THE HUB HAD A CHIPPED PIECE OF EPOXY.

  Patient problems: No Patient Involvement

  MAUDE report 8588591 ↗
• MalfunctionNov 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RETURNED DEVICE ANALYSIS INDICATED THAT THE EPOXY USED TO REINFORCE THE SHAFT WAS FOUND TO BE CHIPPED OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8062079 ↗
• MalfunctionAug 29, 2018Material Discolored; Material Separation; Contamination /Decontamination Problem; Material Discolored; Material Separation; Contamination /Decontamination Problem

  DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODES TCN-10 (LOT 013017) AND TCN-10 (LOT 110916) SHOWED THAT THE EPOXY WAS DISCOLORED AND A CHIP OUT. 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 DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES. EVALUATION OF TCN-15 (LOT 052715) REVEALED A CHIP OUT. THIS FAILURE MECHANISM IS DUE TO EXTERNAL MECHANICAL FORCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7826838 ↗
• MalfunctionJun 7, 2018Break; Material Discolored; Material Separation; Contamination /Decontamination Problem; Break; Material Discolored; Material Separation; Contamination /Decontamination Problem

  THE DEVICE ANALYSIS PERFORMED ON THE (1) RETURNED ELECTRODE TCN-10, LOT 121415 REVEALED THAT THE SHAFT OF THE ELECTRODE WAS FOUND TO BE COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE SHAFT WAS NOT RETURNED FOR ANALYSIS. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFT. VISUAL INSPECTION ALSO REVEALED DISCOLORED EPOXY AND A CHIP OUT. 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 DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES. THE DEVICE ANALYSIS PERFORMED ON THE (2) TCN-10, LOT 122815 REVEALED DISCOLORED EPOXY AND A CHIP OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7578107 ↗
• MalfunctionMay 22, 2018Material Discolored; Material Separation; Material Discolored; Material Separation

  THE DEVICE ANALYSIS PERFORMED ON THE FIVE ELECTRODES REVEALED THAT FOUR OF THEM HAD DISCOLORED EPOXY AND A CHIP OUT. 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 EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES. THE DEVICE ANALYSIS PERFORMED ON THE FIFTH ELECTRODE WAS FOUND TO BE COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE SHAFT WAS NOT RETURNED FOR ANALYSIS. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7531900 ↗
• MalfunctionApr 18, 2018Material Discolored; Material Separation; Material Discolored; Material Separation

  DEVICE EVALUATION WAS PERFORMED ON THE RETURNED PRODUCTS. CSK-TC10 ELECTRODES WITH LOT NUMBERS K510 AND L467 WAS FOUND TO HAVE THE HUB COMPLETELY SEPARATED FROM THE SHAFT DUE TO EXCESSIVE MECHANICAL FORCE. TCN-10 ELECTRODES WITH LOT # 011617 (TOTAL QUANTITY 4) HAD REVEALED THERE WAS DISCOLORATION (BROWN/AMBER) IN THE EPOXY WITH CHIP OUTS. THE DISCOLORED EPOXY OF ALL FOUR ELECTRODES IS UNRELATED TO THE REPORTED COMPLAINT AND IS DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES. TCN-10 ELECTRODE WITH LOT # 111516 WAS FOUND TO HAVE DISCOLORED EPOXY DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7440994 ↗
• MalfunctionJan 17, 2018Material Separation; Material Separation

  THE DEVICE ANALYSIS PERFORMED SHOWED THAT THE SHAFT WAS COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE PLACED UPON THE SHAFT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7200293 ↗
• MalfunctionDec 14, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  THE DEVICE ANALYSIS PERFORMED ON THE RETURNED ELECTRODE REVEALED DISCOLORED EPOXY AND A CHIP OUT. 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 7118054 ↗
• MalfunctionOct 6, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  THE TWO RETURNED ELECTRODES WITH LOT NUMBER 071916 WERE ANALYZED AND VISUAL INSPECTION FOUND 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 6921391 ↗
• MalfunctionOct 5, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  TWO RETURNED ELECTRODES WERE ANALYZED AND VISUAL INSPECTION FOUND 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 6918287 ↗
• MalfunctionOct 5, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  DEVICE EVALUATION ON THE RETURNED ELECTRODE SHOWED THAT THE EPOXY HAS A 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 6917767 ↗
• MalfunctionOct 5, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  THE RETURNED ELECTRODES WERE ANALYZED AND VISUAL INSPECTION FOUND 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 6917672 ↗
• MalfunctionOct 5, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODES FOUND THAT BOTH DEVICES HAD EPOXY CHIPPED 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 6915094 ↗
• MalfunctionOct 3, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  THE DEVICE ANALYSIS PERFORMED ON TWO TCN-10 ELECTRODES (LOT 092415) AND ONE TCN-15 ELECTRODE (LOT 103015) FOUND 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 6911315 ↗
• MalfunctionOct 3, 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 6911098 ↗
• MalfunctionSep 26, 2017Leak/Splash; Leak/Splash

  THE RETURNED ELECTRODE WAS ANALYZED AND 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 6895656 ↗
• MalfunctionSep 19, 2017Break; Material Discolored; Contamination /Decontamination Problem; Break; Material Discolored; Contamination /Decontamination Problem

  DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODES FOUND THAT THE EPOXY HAS A 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 6877475 ↗