COBLATION EC8001-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00817470002164), received between Feb 7, 2019 and Aug 30, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Smoking” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50513098 ↗
• InjuryMar 26, 2026Loose or Intermittent Connection; Output above Specifications; Overheating of Device; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A T&A PROCEDURE, A COBLATOR II WAS TOO HOT AND AN EVAC 70 XTRA REMOVED TOO MUCH TISSUE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING THE SAME COBLATOR II DEVICE AND A NEW EVAC 70 XTRA WAND WAS OPENED. THE PATIENT HAD TO BE TAKEN BACK TO THEATRE ON (B)(6) 2026 EVENING FOLLOWING A BLEEDING POST OPERATIVELY AND THEN WAS DISCHARGED ON (B)(6) 2026. PATIENT CURRENT STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 24701754 ↗
• MalfunctionOct 8, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING AN ADENOTONSILLECTOMY, IT WAS NOTICED THAT THE COBLATOR II CONTROLLER WOULD NOT SWITCH ON. THE HOSPITAL TECHNICIAN BELIEVED THAT THE FUSE MAY HAVE BEEN BURNT. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. THE SURGERY WAS CANCELLED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23246115 ↗
• MalfunctionJun 11, 2025Leak/Splash; Failure to Power Up; Smoking; Leak/Splash; Failure to Power Up; Smoking

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, THE COBLATOR II CONTROLLER HAD SMOKE COMING OUT OF IT AND THERE WAS WHITE FLUID COMING OUT FROM THE BACK SIDE. THE PROCEDURE WAS COMPLETED WITH A CHANGE OF SURGICAL TECHNIQUE, AND A DELAY OF MORE THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186057 ↗
• MalfunctionMay 30, 2025Failure to Deliver Energy; Material Deformation; Failure to Deliver Energy; Material Deformation

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE COBLATOR II CONTROLLER WAS NOT GENERATING PLASMA AND THE WAND CONNECTOR WAS BURNED. THE PROCEDURE WAS SUCCESSFULLY 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 22117585 ↗
• MalfunctionJul 30, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE COBLATOR II CONTROLLER´S ABLATION SETTINGS REMIND ¿0¿ IN-SPITE OF CHANGING WAND AND TRYING TO INCREASE/DECREASE THE ABLATION SETTINGS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. 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 19862403 ↗
• MalfunctionMar 25, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, A COBLATOR II CONTROLLER COAGULATION MODE WAS NOT WORKING. SURGERY RESUMED AFTER A DELAY GREATER THAN 30 MINUTES WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970976 ↗
• MalfunctionJan 26, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE COBLATOR II CONTROLLER HAD NO YELLOW LED LIGHT ON THE CONSOLE AND NO ABLATION OCCURRED. 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 18588190 ↗
• MalfunctionNov 1, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE COBLATOR II CAUGHT FIRE, THERE WAS A LOT OF SMOKE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE IN ANOTHER OPERATING ROOM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047343 ↗
• MalfunctionMay 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, THE COBLATOR II CONTROLLER DID NOT WORK. A DELAY GREATER THAT 30 MINUTES WAS REPORTED. THE PROCEDURE WAS FINISHED WITH A DIFFERENT SURGICAL TECHNIQUE USING BIPOLAR FORCEPS, A COMPETITOR DEVICE. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16871963 ↗
• MalfunctionMay 3, 2023Smoking; Smoking

  IT WAS REPORTED THAT THERE WERE SMOKE FUMES COMING FROM THE COOLING FAN OF THE COBLATOR CONTROLLER. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861796 ↗
• MalfunctionDec 16, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, WHEN PLUGGED IN THE COBLATOR II SYSTEM, THE PIUS BURNED AND THE DEVICE DIDN´T TURN ON. A NEW SMITH AND NEPHEW BACK-UP DEVICE WAS IMMEDIATELY SENT WHICH CAUSED A 2 HOURS DELAY UNTIL THE SURGEON COULD FINISH THE PROCEDURE. THE DOCTOR HAD TO WAKE THE PATIENT UP AND PUT HIM TO SLEEP AGAIN TWO HOURS LATER WHEN THE REPLACEMENT DEVICE ARRIVED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000192 ↗
• MalfunctionDec 13, 2022Smoking; Smoking

  IT WAS REPORTED THAT, DURING SET UP OF A INTRACAPSULAR TONSILLECTOMY PROCEDURE; BEFORE THE PATIENT WAS ANESTHETIZED; WHILE PLUGGING THE COBLATOR II SYSTEM, IT HAD A BURNT SMELL AND SMOKE THAT CAME OUT FROM THE GENERATOR. THE PROCEDURE WAS CANCELLED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15974396 ↗
• MalfunctionDec 11, 2022Smoking; Smoking

  IT WAS REPORTED THAT, DURING SET UP, WHEN THE COBLATOR II CONTROLLER WAS PLUGGED IN, THERE WAS A BURNT SMELL AND SMOKE CAME OUT. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15956522 ↗
• MalfunctionJun 14, 2021Smoking; Smoking

  IT WAS REPORTED THAT WHEN THE COBLATOR II SYSTEM (240 V) WAS READY TO BE CONNECTED, SMOKE OCCURS, AFTER SMOKE, THE PRODUCT CANNOT BE TURNED ON. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. IT IS UNKNOWN WHEN THE INCIDENT OCCURRED AND IF OCCURRED A SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995917 ↗
• MalfunctionFeb 24, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT, AFTER THE INSTALLATION AND ACCEPTANCE OF THE "COBLATOR II SYSTEM (240V)"; IT WAS FOUND THAT THE CONTROLLER COULD BE TURNED ON NORMALLY, BUT THERE WAS NO ENERGY OUTPUT EVEN AFTER THE WAND WAS REPLACED. IT IS UNKNOWN IF THE EVENT HAPPENED DURING SURGERY. THEREFORE, NO PATIENT INVOLVEMENT OR SURGICAL COMPLICATIONS COULD BE CONFIRMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11375567 ↗
• MalfunctionJun 25, 2019Smoking; Smoking

  IT WAS REPORTED THAT THE DEVICE HAD A CRACKLING NOISE WITH SMOKE COMING OUT OF THE CONTROLLER, THE IT STOPPED WORKING. IT IS UNKNOWN WHEN DID THE EVENT OCCURRED, IF A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE OR IF A DELAY WAS CAUSED BY THE DEVICE MALFUNCTION, BUT NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8732143 ↗
• MalfunctionMay 14, 2019Smoking; Mechanics Altered; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT DURING SURGERY THE IRRIGATION CHANNEL WAS NOT WORKING PROPERLY DUE TO WHICH POOR PLASMA, WEAK CUTTING WITH CHARRING AND SMOKE WAS SEEN. THERE WAS NO BACK-UP AVAILABLE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8609728 ↗
• MalfunctionApr 3, 2019Loss of Power

  IT WAS REPORTED THAT DURING SURGERY THE MACHINE SHUT DOWN. NO BACK UP DEVICE WAS AVAILABLE, NO SIGNIFICANT DELAY NOR PATIENT INJURIES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8478900 ↗
• MalfunctionMar 5, 2019Defective Component

  IT WAS REPORTED THAT DURING THREE CASES THE COBLATOR DOES NOT HAVE THE REQUIRED EFFICIENCY FOR A TURBINATE REDUCTION. HOWEVER, THE TURBINATE TISSUE IS STILL AND NOT REDUCE AS WHAT IT CAN PERFORM NORMALLY. NO BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391931 ↗
• MalfunctionMar 5, 2019Defective Component

  IT WAS REPORTED THAT DURING THREE CASES THE COBLATOR DOES NOT HAVE THE REQUIRED EFFICIENCY FOR A TURBINATE REDUCTION. HOWEVER, THE TURBINATE TISSUE IS STILL AND NOT REDUCE AS WHAT IT CAN PERFORM NORMALLY. NO BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391892 ↗
• MalfunctionFeb 7, 2019Defective Component

  IT WAS REPORTED THAT DURING A TURBINATE REDUCTION THE COBLATOR DOES NOT HAVE THE REQUIRED EFFICIENCY FOR A TURBINATE REDUCTION. AFTER SURGERY IT WAS SENT TO TESTING AND IT WAS FOUND THAT THE WANDS CREATE LESS PLASMA THAN USUAL. NO BACK UP DEVICE WAS AVAILABLE AND A NO SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8314623 ↗

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