Coblation EIC8870-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00817470000450), received between Jan 3, 2018 and Aug 16, 2026 — classified as 7 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2026Material Separation

  It was reported that, during a rhinology, electrodes of one (1) PROCISE EZ COBLATOR II came off from the device. The detached metal electrode was identified on a swab after the wand was wiped, and it was confirmed that no electrode material remained in the patient's mouth. The procedure was resumed after a non-significant delay using an equivalent S+N back up. No further complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50266596 ↗
• MalfunctionDec 24, 2025Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, UPON CHECKING THE TIP OF THE PRECISE WAND, THE TIP ELECTRODE WAS MISSING. THE BROKEN PIECE WAS NOT FOUND IN A PATIENT'S BODY. THE SURGERY WAS COMPLETED USING AN EQUIVALENT SN BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888849 ↗
• MalfunctionDec 22, 2025Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, UPON CHECKING THE TIP OF THE PRECISE WAND, THE TIP ELECTRODE WAS MISSING. AFTER THAT, THE SURGEON USED A SECOND PRECISE WAND, BUT THE SAME FAILURE OCCURRED. THE BROKEN PIECE WAS NOT FOUND IN A PATIENT'S BODY. THE SURGERY WAS COMPLETED USING AN EQUIVALENT SN BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872382 ↗
• MalfunctionSep 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE ELECTRODE TIP OF THE PROCISE EZ COBLATOR II WAS MISSING, BUT THE BROKEN PIECE WAS FOUND IN THE PATIENT'S BODY AND THEN, IT WAS RETRIEVED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED. THERE WAS A SURGICAL DELAY OF ONE (1) HOUR AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23116318 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ADENOTONSILLECTOMY, THE ELECTRODE OF THE PROCISE EZ WAND FRACTURED. THE BROKEN PIECES WERE NOT SEEN TO BE REMOVED, BUT WERE NOT VISIBLE ON THE X-RAY, SO WERE ASSUMED TO HAVE BEEN REMOVED INTRAOPERATIVELY POSSIBLY BY SUCTION. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 30 MINUTES USING A SUCTION MONOPOLAR COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21438654 ↗
• InjuryAug 5, 2024Arcing; Arcing

  IT WAS REPORTED THAT DURING A BILATERAL DCR PROCEDURE (DACRYOCYSTORHINOSTOMY), IT WAS OBSERVED BY THE OPERATORS THAT THE PRECISE EZ COBLATOR WAND DIFFUSED ELECTRIC CURRENT INTO THE LOWER CORNEA OF THE PATIENT CAUSING STROMAL SCAR INFERIOR RIGHT OFF OPTICAL AXIS. A SLIGHT WHITE SPOT APPEARED IN THE LOWER CORNEA, IT APPEARED TO BE SUPERFICIAL. THE PROCEDURE WAS COMPLETED USING COLD INSTRUMENTS WITH NO SURGICAL DELAY. THE PATIENT IS IN HEALING PROGRESS AS THE LESION STILL PRESENT USING OINTMENT AND MEDICATION APPLIED TO THE INJURED EYE AS RECOMMENDED BY THE OPHTHALMOLOGIST. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Corneal Clouding/Hazing

  MAUDE report 19913781 ↗
• MalfunctionMay 10, 2023Degraded; Material Separation; Degraded; Material Separation

  IT WAS REPORTED THAT THE PROCISE EZ ELECTRODE FELL OFF WHEN IT WAS USED FOR A FEW MINUTES. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. CURRENT PATIENT STATUS IS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901739 ↗
• InjuryDec 23, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE SLICE ELECTRODE OF THE PROCISE DISAPPEARED. PROBABLY SUCTION WAS PERFORMED TO REMOVE ANY PIECES INSIDE THE PATIENT. X-RAY DID NOT REVEALED ANYTHING LEFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 11066458 ↗
• InjuryDec 23, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE SLICE ELECTRODE OF THE PROCISE DISAPPEARED. PROBABLY SUCTION WAS PERFORMED TO REMOVE ANY PIECES INSIDE THE PATIENT. X-RAY DID NOT REVEALED ANYTHING LEFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 11066443 ↗
• InjurySep 25, 2020Break; Break

  IT WAS REPORTED THAT THE HORSESHOE OF THE WAND WAS LOST HALF AN HOUR AFTER THE OPERATION WITH 0 MINUTES OF USE WITH SETTINGS 7/3. A NEW PRODUCT WAS REPLACED IMMEDIATELY. AT 3:00 P.M., THE HORSESHOE WAS LOST AGAIN AND SOLVED USING A BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AND IT IS UNKNOWN IF THE MALFUNCTION CAUSED A DELAY.

  Patient problems: Injury

  MAUDE report 10589436 ↗
• InjurySep 25, 2020Break; Break

  IT WAS REPORTED THAT THE HORSESHOE OF THE WAND WAS LOST HALF AN HOUR AFTER THE OPERATION WITH 0 MINUTES OF USE WITH SETTINGS 7/3. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10588326 ↗
• InjurySep 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, WHEN THE TONSIL WAS ABLATED WITH THE DEFAULT GEAR OF THE "PROCISE EZ WAND", THE ELECTRODE FELL OFF. ALTHOUGH A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, IT IS UNKNOWN IF THERE WAS A SURGERY DELAY. NO 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 Information

  MAUDE report 10558165 ↗
• InjurySep 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, WHEN THE TONSIL WAS ABLATED WITH THE DEFAULT GEAR OF THE "PROCISE EZ WAND", THE ELECTRODE FELL OFF. AFTER THE LOSS, X-RAY OBSERVATION WAS MADE AND NO ELECTRODE WAS FOUND IN THE BRAIN. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 2 HOURS USING A BACK-UP DEVICE. NO FURTHER 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 Information

  MAUDE report 10558155 ↗
• MalfunctionJan 3, 2018Component Missing

  IT WAS FOUND THAT THE DEVICE WAS NOT WORKING. UPON FURTHER INVESTIGATION, IT WAS NOTICE THAT THE FLAT SCREEN ELECTRODE WAS MISSING FROM THE WAND. IT IS UNSURE IF IT WAS SUCKED UP INTO THE WAND OR IF IT ENDED UP IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7159555 ↗