Coblation EC8000-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00817470001976), received between Aug 5, 2020 and Jun 1, 2026 — classified as 7 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K030108); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Overheating of Device

  IT WAS REPORTED THAT, THE CORD OF THE COBLATOR II CONTROLLER OVERHEATED. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355858 ↗
• MalfunctionSep 30, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, TWO DIFFERENT WANDS DID NOT WORK WHEN CONNECTED TO THE CONSOLE, THEREFORE IT WAS NOTICED THAT THE COBLATOR II WAS DEFECTIVE. THE PROCEDURE WAS RESUMED, WITH A 40 MINUTE SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP. THE PATIENT NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23180030 ↗
• MalfunctionAug 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE COBLATOR II CONTROLLER WAS FAULTY. SURGERY WAS COMPLETED USING A COMPETITOR DEVICE INSTEAD, WITH A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901376 ↗
• MalfunctionJul 12, 2025Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE COBLATOR II CONTROLLER WAS UNABLE TO PRODUCE THE ADEQUATE PLASMA OUTPUT IN THE WAND AS REQUIRED FOR THE ABLATION. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22488805 ↗
• MalfunctionMay 27, 2025Infusion or Flow Problem; Insufficient Device Problem Information; Infusion or Flow Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TURBINATE REDUCTION, THE FA COBLATOR II CONTROLLER DID NOT WORK PROPERLY WHEN USING THE COAG PORTION AND SUCTION MONOPOLAR. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30MIN, THERE WAS NO BACK-UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088148 ↗
• MalfunctionApr 14, 2025Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE COBLATOR II CONTROLLER DID NOT FORM PLASMA IN THE WAND, AND IT COULD NEITHER ABLATE NOR COAGULATE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21836330 ↗
• MalfunctionMar 6, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING AN ENT SURGERY, THE COBLATOR II CONTROLLER WOULD NOT BOOT UP. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543265 ↗
• MalfunctionNov 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE FOOT CONTROL WAS FAULTY. SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613173 ↗
• MalfunctionSep 20, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE COBLATOR II CONTROLLER'S ARROWS ON THE SCREEN USED TO CHANGE THE SETTINGS DID NOT WORK. THERE WAS A CHANGE IN THE SURGICAL TECHNIQUE AND A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273544 ↗
• MalfunctionAug 22, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY, WHEN THE WANDS WERE CONNECTED TO THE COBLATOR II CONTROLLER, THE SETTINGS WERE COMING UP 0&3 AND NOT TO THE DEFAULT SETTINGS 7&3. SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034886 ↗
• MalfunctionJul 15, 2024Failure to Deliver Energy; Mechanical Jam; Failure to Deliver Energy; Mechanical Jam

  IT WAS REPORTED THAT DURING A T&A, FOUR EVAC 70 WANDS FAILED WHEN CONNECTED TO THE CONTROLLER. TWO WANDS WOULD REGISTER SETTINGS FOR ABLATE AND COAG BUT WOULD NOT DELIVER ENERGY, AND THE OTHER TWO WANDS WOULD REGISTER SETTINGS 0'S FOR ABLATE AND COAG OPTIONS WHEN PLUGGED IN. THE FA COBLATOR CONTROLLER, THE SETTINGS REGISTERED ON THE CONTROLLER, BUT IT WAS NOT DELIVERING THE ENERGY TO THE TISSUE. THE PROCEDURE WAS CANCELLED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746878 ↗
• MalfunctionJun 21, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE COBLATOR GENERATOR WAS NOT REGISTERING THAT THE FLOW CONTROL UNIT WAS ATTACHED TO THE UNIT, HOWEVER, WHEN PRESSING ON THE FOOT CONTROL ASSEMBLY, WITH A WAND ATTACHED TO THE GENERATOR, THE PIN WITHIN THE FLOW CONTROL UNIT WOULD START TO FLICKER ON AND OFF. THE PIN WITHIN THE FLOW CONTROL UNIT WAS NEVER PERMANENTLY OPEN TO FEED THE SALINE LINE THROUGH. THE USER TESTED THE GENERATOR WITH DIFFERENT FLOW CONTROL UNITS AND CABLES BUT STILL HAD THE SAME ISSUE. THE PROCEDURE WAS CANCELLED. NO FURTHER COMPLICATION REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19589132 ↗
• MalfunctionJun 5, 2024Energy Output Problem; Communication or Transmission Problem; Energy Output Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, WHEN THE WAND WAS PLUGGED TO THE COBLATOR II CONTROLLER IT DID NOT SET THE DEFAULT 7-3. IT POWERED ON, BUT IT DID NOT ALLOW ANY COBLATION. THERE WAS A A DELAY GREATER THAN 30 MINUTES REPORTED. THERE WAS A BACK-UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472933 ↗
• MalfunctionJan 16, 2024Corroded; Overheating of Device; Corroded; Overheating of Device

  IT WAS REPORTED THAT THE COBLATOR II CONTROLLER WAS HOT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519252 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TURBINATE REDUCTION SURGERY WITH COBLATOR II CONTROLLER, HAS RESULTED IN A DELAYED POSTOPERATIVE SECONDARY ATROPHIC RHINITIS AND AN IATROGENIC BREATHING DISORDER, FORMALLY DIAGNOSED AS "EMPTY NOSE SYNDROME" (J34.89 (ICD-10-CM)]) IN BOTH NASAL VALVES, HAVING A DIRECT CONNECTION TO COBLATION THAT RESULTED IN SEVERE DAMAGE OF INFERIOR TURBINATE. THE INFERIOR TURBINATE VOLUME HAS BEEN REDUCED BY (B)(4) BILATERALLY. NASAL BURNING, DYSPNEA, CENTRAL SLEEP APNEA (FROM MISSING TRPM8 RECEPTORS), JOLTS BEFORE SLEEP, RESTLESS LEGS AT NIGHT, PARADOXICAL NASAL OBSTRUCTION, DEPRESSION, ANXIETY, FATIGUE, OCCASIONAL EAR FULLNESS, INTERNAL VALVES COLLAPSE, DISRUPTED NASAL CYCLE, 30-40% DECREASE IN SENSE OF SMELL, DECREASE IN NASAL AIRFLOW RESISTANCE AND NASAL AIRFLOW PATTERN, NERVE DAMAGE, SEVERE INTRANASAL DRYNESS (FROM HISTOPATHOLOGICAL AND SURFACE DAMAGE TO MUCOSA), LEADING TO FREQUENT CLOGGING OF POSTERIOR NASAL PASSAGES, AND LACK OF NATURAL INTRANASAL AIR WARMING, HUMIDIFICATION AND FILTERING, AS INFERIOR TURBINATES ARE NOW SEVERELY AND IRREVERSIBLY DAMAGED. THIS INFERIOR TURBINATE DAMAGE HAS RESULTED IN NASAL BREATHING BECOMING UNNATURAL, EQUAL TO MOUTH BREATHING I

  Patient problems: Anxiety; Apnea; Depression; Dyspnea; Fatigue; Fibrosis; Nasal Obstruction; Sleep Dysfunction; Upper Respiratory Tract Injury

  MAUDE report 18401064 ↗
• MalfunctionNov 6, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING A PROCEDURE, A COBLATOR II CONTROLLER STARTED SMOKING. SURGERY CONTINUED WITHOUT ANY DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074415 ↗
• InjurySep 29, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE COBLATOR II CONTROLLER WAS NOT REGISTERING. THE PROCEDURE HAD TO BE CANCELLED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17843966 ↗
• MalfunctionAug 3, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A PROCEDURE, A COBLATOR II CONTROLLER WAS NOT WORKING; WHEN IT WAS PLUGGED IT SWITCHED OFF. SURGERY RESUMED AFTER A DELAY GREATER THAN 30 MINUTES WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455815 ↗
• MalfunctionMar 29, 2023Smoking; Arcing; Smoking; Arcing

  IT WAS REPORTED THAT DURING SET UP OF A PROCEDURE, THE FA COBLATOR II CONTROLLER WAS SPARKING AT THE SIDE AND WHEN PLUGGED IN THE WAND IT STARTED SMOKING. BACK UP DEVICE WAS AVAILABLE AND NO DELAY REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640930 ↗
• MalfunctionFeb 23, 2023Arcing; Arcing

  IT WAS REPORTED THAT DURING SET UP, THE COBLATOR II CONTROLLER STARTED SPARKLING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432579 ↗
• MalfunctionFeb 22, 2023Smoking; Smoking

  IT WAS REPORTED THAT THE COBLATOR II CONTROLLER SMOKED WHEN TURNED ON . NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421044 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW APPLICATION OF PLASMA-MEDIATED COLD ABLATION IN OTORHINOLARYNGOLOGY, 1 PATIENT HAD PHARYNGOSTENOSIS DUE TO ADHESIONS AFTER A TONSILLECTOMY PROCEDURE USING A COBLATOR II CONTROLLER DEVICE. A PHARYNGOPLASTY WAS RECOMMENDED BUT IT IS UNKNOWN IF IT WAS PERFORMED. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s); Stenosis

  MAUDE report 15843606 ↗
• MalfunctionSep 17, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING A SOFT PALATE AND TURBINATE REDUCTION PROCEDURE, THE COBLATOR CONTROLLER FAILED TO PERFORM AS EXPECTED BUT IT IS UNKNOWN HOW. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15443201 ↗
• MalfunctionJun 6, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE FOOT CONTROL ASSEMBLY COAGULATION PEDAL GOT STUCK KEEPING THE SYSTEM ON CONTINUOUSLY. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT CURRENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604051 ↗
• MalfunctionJun 2, 2022No Display/Image; Arcing; No Display/Image; Arcing

  IT WAS REPORTED THAT COBLATOR II CONTROLLER WAS NOT READING THE WANDS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. DURING INVESTIGATION, IT WAS FOUND ARC/BURN DAMAGE IN THE WAND PORT AND THE UNITS COAG DISPLAY IS BLANK IS THE TOP RIGHT CORNER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575760 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030108. One submission often covers many models, so check the product and lot details in each record.

• Z-1323-2015 · Feb 20, 2015 · Terminated
  Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surger