Coblation EICA5874-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00817470004007), received between Jan 30, 2018 and Feb 2, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Arcing” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Melted

  IT WAS REPORTED THAT, DURING A T&A PROCEDURE, THE TIP OF THE PRECISE COBLATOR MELTED. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE, HOWEVER THERE WAS A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240953 ↗
• MalfunctionFeb 2, 2026Melted

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY AND ADENOIDECTOMY, THE TIP OF AN EVAC 70 XTRA WAND MELTED. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240568 ↗
• MalfunctionFeb 9, 2023Arcing; Arcing

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, THE EVAC 70 XTRA COBLATOR II WAND WAS ARCING WHILE USING THE SETTINGS 9-5. THE SETTINGS WERE MOVED TO 8-4 AND IT HELPED, BUT STILL NOTICED ARCING. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 10 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335121 ↗
• InjuryJan 19, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE USING AN EVAC 70 XTRA COBLATOR II WAND, A BURN WAS NOTICED IN THE MOUTH IN AN AREA WHERE THE TIP WAS NOT ACTIVATED AT ANY POINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 1-2 MINUTES USING A BACK-UP DEVICE. THE BURN WAS EVALUATED BY A PLASTIC SURGEON, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 16206695 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY/ADENOIDECTOMY USING A EVAC COBLATION WAND CONNECTED TO A COBLATOR CONTROLLER, THE WAND CONDUCTED THROUGH AN ALLIS CLAMP BURNT THE LIP OF THE PATIENT. IT WAS A SECOND DEGREE BURN WITH SHALLOW ULCERATION AT SITE WHICH WAS TREATED WITH ANTIBIOTIC OINTMENT AND IT IS NOW COMPLETELY HEALED UP. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY BY CHANGING THE SURGICAL TECHNIQUE TO ELECTROCAUTERY WITH SUCTION INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 13934813 ↗
• MalfunctionMar 29, 2022Smoking; Sparking; Smoking; Sparking

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY/ADENOIDECTOMY USING A EVAC COBLATION WAND CONNECTED TO A COBLATOR CONTROLLER, WHEN THE WAND WAS BEING USED, IT SPARKED AND PRODUCED SMOKE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY BY CHANGING THE SURGICAL TECHNIQUE TO ELECTROCAUTERY WITH SUCTION INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934802 ↗
• InjuryAug 18, 2021Overheating of Device; Overheating of Device

  IT WAS REPORT THAT DURING TONSIL SURGERY, THE SIDE OF THE COBLATOR WAND WAS HOT AND LEFT A BURN MARK NEXT TO THE TONSILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Burn(s)

  MAUDE report 12337726 ↗
• MalfunctionApr 15, 2021Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT THE EVAC 70 WOULD NOT WORK AFTER PLUGGING IT IN. NO ARC NOTED PER PHYSICIAN. UNPLUGGED AND RESTARTED MACHINE AND STILL WAND WOULD NOT WORK, THERE WAS AN AUDIBLE TONE BUT THE STAFF AND DOCTOR SAID IT SOUNDED DIFFERENT THAN NORMAL. NO CASE INVOLVED. 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 11671368 ↗
• MalfunctionFeb 11, 2021Arcing; Arcing

  IT WAS REPORTED THAT DURING A SURGERY, THE EVAC 70 WAND WAS ARCHING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11319822 ↗
• MalfunctionSep 6, 2018Sparking

  IT WAS REPORTED THAT THE DEVICE SPARKED.

  Patient problems: No Information

  MAUDE report 7851437 ↗
• MalfunctionAug 17, 2018Defective Device

  IT WAS REPORTED THAT THE DEVICE DID NOT ABLATING FOR COAGING PROPERLY IT WAS WEAK. THERE WAS NO BACK UP DEVICE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794234 ↗
• InjuryAug 12, 2018Decrease in Suction

  IT WAS REPORTED THAT THE WAND WAS NOT SUCKING NACI BACK INTO THE TIP OF THE WAND. PATIENT EXPERIENCED POST OPERATIVE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7775823 ↗
• InjuryJan 30, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COBLATOR II BURNED A PATIENT ON THE LIP.

  Patient problems: Burn, Thermal

  MAUDE report 7229210 ↗