Coblation EIC8898-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00817470007473), received between Feb 28, 2019 and Aug 7, 2026 — classified as 1 death, 14 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Break

  It was reported that, during a surgery, the electrode tip wire of one (1) PROCISE MAX COBLATOR II broke. The procedure was resumed using an equivalent S+N back-up and it is unknown whether this caused any delay. No further complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184516 ↗
• MalfunctionApr 28, 2026Overheating of Device

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY PROCEDURE, THE PROCISE COBLATOR'S SALINE OUTLET IN THE SUCTION END WAS HOT. THE WEREWOLF SETTING WAS ADJUSTED TO 7 IN ABLATION AND FLOW RATE TO 5. THE PROCEDURE WAS RESUMED, WITH 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 25024058 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A REDUCTION OF THE LINGUAL TONSILS, THE SURGEON DEVIATED LATERALLY AND COBLATED THE LINGUAL ARTERY. FOLLOWING THIS INCIDENT, SEVERE BLEEDING BROUGHT THE PROCEDURE TO AN IMMEDIATE HALT. A COMPRESS WAS PLACED, AND AN ATTEMPT WAS MADE TO ACHIEVE HEMOSTASIS USING BIPOLAR PROBE, WHICH PROVED IMPOSSIBLE BECAUSE THE TEAR WAS TOO POSTERIOR. A SECOND COMPRESS WAS PLACED, FOLLOWED BY TRANSFER OF THE PATIENT TO ANOTHER ROOM SO THAT RADIOLOGISTS COULD EMBOLIZE THE ARTERY. THE PROCEDURE WAS CANCELLED. FOLLOWING THE EMBOLIZATION PERFORMED ON MARCH 16TH, SHE REMAINED IN THE INTENSIVE CARE UNIT UNTIL THE AFTERNOON OF TUESDAY, MARCH 17. HER CONDITION IS STABLE. IN THE AFTERNOON OF MARCH 17TH, SHE WAS READMITTED TO THE OPERATING ROOM. APPROXIMATELY 7 COMPRESSES WERE APPLIED BY PRESSING ON THE BLEEDING AREA TO STOP THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24824364 ↗
• MalfunctionMar 30, 2026Material Integrity Problem

  IT WAS REPORTED THAT, DURING THE INITIAL STAGE OF THE ADENOIDECTOMY, THE TIP OF THE PROCISE MAX WAND GOT BROKE. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724177 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT, DURING THE INITIAL STAGE OF THE ADENOIDECTOMY, THE TIP OF THE PROCISE MAX WAND GOT BROKE. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724099 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT, DURING THE INITIAL STAGE OF THE SURGERY, THE TIP OF THE PROCISE MAX WAND GOT BROKE. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED, AND IT IS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24723081 ↗
• MalfunctionMar 25, 2026Suction Problem

  IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE, THE PROCISE MAX WAND BECAME CLOGGED AFTER TWO MINUTES OF USE. ATTEMPTS WERE MADE TO REMOVE THE CLOG AND CLEAN THE TIP, BUT THE OBSTRUCTION PERSISTED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP, AFTER A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688722 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY AND ADENOIDECTOMY, IT WAS NOTICED THAT THE ELECTRODE OF THE PROCISE MAX COBLATOR WAND RUPTURED. THE ELECTRODE BROKE INSIDE THE TIP AND, WHEN REMOVED ALONG WITH THE OTHER INSTRUMENTS, NO PARTS REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24448151 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT, DURING HALFWAY A TONSILLECTOMY, THE ELECTRODE TIP OF THE PROCISE WAND BROKE. THE BROKEN PART WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF 20 MINUTES USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335394 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A NASAL MASS FESS AND SEPTOPLASTY WHERE THE EVAC 70 XTRA COBLATOR WAS USED, THE PATIENT GOT INFECTED WITH CLIVAL BONE OSTEOMYELITIS. IT IS UNKNOWN HOW WAS THE PATIENT TREATED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Osteomyelitis

  MAUDE report 23075284 ↗
• MalfunctionJul 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, TWO PROCISE MAX WERE GETTING DAMAGED EASILY (THE METAL ELECTRODE WAS DAMAGED). 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 22682815 ↗
• MalfunctionJul 28, 2025Melted; Melted

  IT WAS REPORTED THAT DURING AN ENT SURGERY, THE PROCISE MAX COBLATOR WAND WAS GETTING DAMAGED VERY QUICKLY AND THE ELECTRODE WAS MELTED. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628409 ↗
• MalfunctionJul 28, 2025Degraded; Melted; Material Twisted/Bent; Degraded; Melted; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ENT SURGERY, THE ACTIVE ELECTRODE OF TWO (2) PROCISE MAX COBLATOR WANDS WAS GETTING DAMAGE VERY QUICKLY, THE ELECTRODES WERE MELTED. 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 22627023 ↗
• MalfunctionJun 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING ENT PROCEDURE, TEN (10) PROCISE MAX COBLATOR II WANDS WERE GETTING DAMAGED EASILY AND NOT GIVING OPTIMUM RESULTS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283427 ↗
• MalfunctionMay 29, 2025Break; Degraded; Material Twisted/Bent; Break; Degraded; Material Twisted/Bent

  IT WAS REPORTED THAT THE METAL WIRE OF THE PROCISE WAND BROKE. IT IS UNKNOWN WHEN THE EVENT TOOK PLACE, IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WAS A DELAY. THERE WAS A BACK UP DEVICE AVAILABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110153 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A TURBINECTOMY PROCEDURE, THE PROCISE COBLATOR ELECTRODE BROKE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919066 ↗
• MalfunctionMar 5, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE PROCISE MAX COBLATOR II WAS DEFECTIVE AS IT ONLY HEATED AND WAS SMOKING TOO MUCH. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525220 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY, THE PROCISE MAX COBLATOR WAND WORKED PERFECTLY TO ABLATE THE TONSILS. WHEN THE SURGEON RETRACTED THE SOFT PALLET TO ADDRESS THE ADENOIDS, IT WAS NOTICED THAT THERE WAS SOME SUPERFICIAL SLOUGHING MIDWAY DOWN POSTERIOR PHARYNX, VERY SUPERFICIAL. IT WAS DECIDED TO STOP WITH COBLATION AND RESUME WITH SUCTION CAUTERY. WHEN THE ADENOIDS WERE BEING REMOVED WITH SUCTION CAUTERY, THEY CAME OUT IN CHUNKS. AFTER THE ADENOIDS WERE ADDRESSED, A GLIDESCOPE WAS USED AND IT WAS NOTICED THAT THE SLOUGHING WAS EVIDENT ALL THE WAY TO THE LARYNX. AT THIS POINT, THE NURSE DID REALIZE THAT THEY REPLACED THE SALINE BAG WITH LACTATED RINGER¿S. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT SEEMED OK POST PROCEDURE.

  Patient problems: Unspecified Tissue Injury; Voice alteration

  MAUDE report 20757411 ↗
• MalfunctionNov 18, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN INTRACAPSULAR TONSILLECTOMY, THE CORD OF THE PROCISE COBLATOR WAND TURNED VERY WARM AS SOON AS THE CASE BEGAN. SURGEON WAS UNABLE TO CONTINUE WITH THE WAND DESPITE TRYING TO INCREASE THE SALINE FLOW. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20716304 ↗
• DeathJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INTRACAPSULAR TONSILLECTOMY PROCEDURE, THE SPECIALIST USED A PROCISE MAX COBLATOR WAND IN A 5-YEAR-OLD PATIENT ALLEGEDLY WITHOUT ANY TRAINING OR TECHNICAL KNOWLEDGE FOR A TONSIL REMOVAL AND ADENOID. A LARGE BLEED WAS REPORTED AFTER THE SPECIALIST CONFUSED THE EQUIPMENT'S PEDAL EXCHANGING CAUTERIZATION FOR ABLATION AND HAD TO BE CONTAINED DURING SURGERY AFTER GREAT DIFFICULTY. THE ARTERY WAS HIT AGAIN, OPENING THE BLEEDING WHICH HAD TO BE CONTAINED WITH SURGICAL STITCHES AS IT WAS NO LONGER POSSIBLE TO CAUTERIZE IT WITH COBLATION OR BIPOLAR CAUTERY. THE PROCEDURE WAS COMPLETED USING THE SAME REPORTED DEVICE. THERE WAS NO SURGICAL DELAY. THE PATIENT WAS DISCHARGED 12 HOURS AFTER THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT RETURNED 2 DAYS LATER WITH BLEEDING; WAS DISCHARGED AGAIN, BUT AFTER 24 HOURS THE PATIENT STARTED COUGHING WITH HEAVY BLEEDING AND WAS RUSHED TO THE NEAREST HOSPITAL, BUT THE PATIENT HAD ALREADY PASSED AWAY. AN AUTOPSY CONFIRMED THE RUPTURE OF THE TONSILLAR ARTERY, 6 DAYS AFTER THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19454200 ↗
• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE PATIENT HAD A MUSCLE SPASM IN THE LOWER POLE OF THE AMYGDALA, WHEN THE SURGEON HAD THE PROCISE MAX COBLATOR II WAND IN ABLATE MODE, THE SPASM CAUSED TO MISMOVE THE PROBE AND CATCH THE PILLAR MUSCLE, CAUSING CAUSED BLEEDING. THEN, WHEN TRYING TO COAGULATE THE SITE, THE SURGEON USED THE WRONG PEDAL AND PRESSED ABLATE (YELLOW) INSTEAD OF COAG (BLUE) FOR A FRACTION OF A SECOND, AND THEN CLOTS NORMALLY. THE PROCEDURE WAS FINISHED WITH A THE SAME DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18406745 ↗
• MalfunctionDec 21, 2023Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, A PROCISE MAX COBLATOR II WAS SMOKING, DESPITE BEING CHECKED THE SUCTION TUBE BECAME HOT; AND WHEN IT WAS RETRIEVED THE TONSILLAR TISSUE "BURNED" WITHOUT SPRAYING IT; WHICH CAUSED THAT THE TONSILLAR TISSUE TO BECOME MORE DENSE; HOWEVER NO CONSEQUENCES TOOK PLACE. THE DEVICE WAS INITIALLY BEING USED IN A 9 SETTING, WHICH WAS REDUCED TO 7 AND LASTLY TO 5. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY LESS THAN 30 MINUTES, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378123 ↗
• MalfunctionDec 20, 2023Melted; Arcing of Electrodes; Melted; Arcing of Electrodes

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, WHILE THE SURGEON WAS USING THE PROCISE MAX WAND ON THE YELLOW PEDAL, THERE WAS A BIGGER PLASMA ARC THAT CAME FROM THE TIP AND THE ELECTRODE DISSOLVED PARTIALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PER PRELIMINARY RESULTS OF THE INVESTIGATION, THE FUNCTIONAL EVALUATION SHOWED THE WAND PRODUCED A SMALL AMOUNT OF PLASMA JUST BEFORE ARCING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18369880 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ADENOID PROCEDURE, THE PROCISE MAX COBLATOR II WAND WAS BLOCKED, AND THE SURGEON PASSED THE WAND TO THE SCRUB NURSE TO CLEAN THE TIP OF THE WAND. WHILE THE SCRUB WAS CLEANING THE TIP OF THE WAND WITH A GAUZE, THE NURSE NOTICED THAT THE METAL PLATE OF THE WAND WAS ON THE GAUZE. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199781 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A CIT PROCEDURE, THE RESIDENT WAS STILL ON SETTING 9 AND MISUSED THE PEDALS TO COAGULATE A BLEEDER WITH A PROCISE MAX COBLATOR, AS A RESULT THEY WENT RIGHT THROUGH THE CAPSULE AND HAD TO USE A STANDARD BIPOLAR DEVICE TO CAUTERIZE THE BLEED. THE BLEED STOPPED AND THE PATIENT WENT HOME. AFTER THE PROCEDURE, THE PATIENT GOT PNEUMONIA, COUGH A LOT TO THE POINT WHERE THE SCAB CAUSED BY THE BIPOLAR DEVICE FELL AND CAUSED AN IMPORTANT RE-BLEED AT DAY 8 WHICH REQUIRED THE PATIENT TO BE RUSHED TO THE HOSPITAL. THE PATIENT WAS RE-OPERATED TO STOP THE BLEEDING. THE BLEED WAS CONTROLLED AND THE PATIENT STATUS WAS GOOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16649374 ↗