Coblation EICA8875-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00817470004335), received between Feb 20, 2019 and Apr 20, 2026 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Arcing” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Peeled/Delaminated

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY AND ADENOIDECTOMY, A PROCISE EZ VIEW WAND HAD AN IRREGULARITY ON THE SHEATH, IT WAS EXPOSED. THE PROCEDURE WAS RESUMED, AFTER A DELAY OF LESS THAN 5 MINUTES, USING AN EQUIVALENT S+N BACK-UP. AFTER THE PROCEDURE, A SIMILAR APPEARANCE WAS NOTED ON A SECOND WAND. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924094 ↗
• MalfunctionDec 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING SET UP, THE PROCISE EZ VIEW COBLATOR WAND MALFUNCTIONED. THE BLACK PLASTIC SHEATH OF THE WAND WAS SLICED. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824810 ↗
• MalfunctionMar 20, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE WHOLE PROCISE COBLATOR WAND WAS GETTING VERY HOT AND THE TIP WAS SMOKING. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16572791 ↗
• InjuryMay 4, 2022Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE, THE SURGEON FELT A SHOCK FROM THE PROCISE WAND WHEN HE PLACED HIS FOOT ON THE COBLATOR PEDAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 14274438 ↗
• InjuryJul 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿COBLATION INTRACAPSULAR TONSILLECTOMY (TONSILLOTOMY) IN CHILDREN: A PROSPECTIVE STUDY OF 500 CONSECUTIVE CASES WITH LONG-TERM FOLLOW-UP¿; AFTER SURGERY WITH A PROCISE EZ VIEW COBLATION WAND, TWO PATIENTS HAD A SMALL SECONDARY BLEED AT APPROXIMATELY ONE WEEK AFTER SURGERY. THE BLEED SETTLED SPONTANEOUSLY AT HOME; THE PATIENTS RETURNED FOR OBSERVATION AND RE-ADMISSION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12222712 ↗
• InjuryJul 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿COBLATION INTRACAPSULAR TONSILLECTOMY (TONSILLOTOMY) IN CHILDREN: A PROSPECTIVE STUDY OF 500 CONSECUTIVE CASES WITH LONG-TERM FOLLOW-UP¿; AFTER SURGERY WITH A PROCISE EZ VIEW COBLATION WAND 12 PATIENTS HAD RECURRENT NASAL OBSTRUCTION, OBSTRUCTIVE SLEEP APNEA & SLEEP DISORDERED BREATHING. THE COMPLICATION WAS TREATED WITH REVISION ADENOIDECTOMY SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Apnea

  MAUDE report 12222711 ↗
• InjuryJul 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿COBLATION INTRACAPSULAR TONSILLECTOMY (TONSILLOTOMY) IN CHILDREN: A PROSPECTIVE STUDY OF 500 CONSECUTIVE CASES WITH LONG-TERM FOLLOW-UP¿; AFTER SURGERY WITH A PROCISE EZ VIEW COBLATION WAND 12 PATIENTS HAD RECURRENT OBSTRUCTIVE SLEEP APNEA AND TONSILLITIS SYMPTOMS. THE PATIENTS WERE TREATED WITH REVISION TONSIL SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Apnea

  MAUDE report 12222710 ↗
• MalfunctionJan 5, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ENDO SINUS SURGERY, THE PROCISE WANDS WERE DEFECTIVE. THE PROCEDURE WAS SUCCESSFULLY USING A BACK-UP DEVICE. A SIGNIFICANT DELAY GREATER THAN 30 MIN WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11116225 ↗
• MalfunctionJul 16, 2019Arcing; Arcing

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE HAD ELECTRICAL SPARKS. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8794564 ↗
• MalfunctionJul 15, 2019Sparking; Sparking

  IT WAS REPORTED THAT DURING THE SURGERY THE WAND STARTED TO SPARK , AS PER REPORTER THE WANT CONTINUED TO SPARK. NO PATIENT INJURIES OR DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8788736 ↗
• MalfunctionJul 11, 2019Arcing; Sparking; Arcing; Sparking

  IT WAS REPORTED THAT DURING SURGERY THE WAND, SPARKED AND CONTINUED TO SPARK. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8780074 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT EXPERIENCED A POST-OPERATIVE REBLEED. ALL FURTHER INFORMATION IS STILL UNKNOWN.

  Patient problems: Blood Loss

  MAUDE report 8620235 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT EXPERIENCED A POST-OPERATIVE REBLEED. ALL FURTHER INFORMATION IS STILL UNKNOWN.

  Patient problems: Blood Loss

  MAUDE report 8620234 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TONSILLECTOMY PROCEDURE, THE PATIENT EXPERIENCED A POST-OPERATIVE REBLEED. ALL FURTHER INFORMATION IS STILL UNKNOWN.

  Patient problems: Blood Loss

  MAUDE report 8620233 ↗
• MalfunctionFeb 20, 2019Smoking; Arcing; Sparking; Temperature Problem

  IT WAS REPORTED THAT DURING TONSILLECTOMY, THE DEVICE BEGAN SMOKING, THE DEVICE WAS REPORTED AS MUCH WARMER THAN NORMAL DURING USE BY THE SURGEON. THERE WERE NO SPARKING OR ARCING DURING THE CASE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY, DELAY AND PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353878 ↗