Coblation EICA8898-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00817470003888), received between Sep 22, 2017 and Jan 26, 2026 — classified as 7 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (6 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Material Separation

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE BLACK PIECE LEADING UP TO THE TIP OF A PROCISE MAX COBLATOR WAND TORE INTO THE SIDE OF THE PATIENT'S SKIN WHERE IT WAS RUBBING IT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176990 ↗
• MalfunctionJan 22, 2026Material Separation

  IT WAS REPORTED THAT, DURING AN ADENOID REMOVAL SURGERY, THE BLACK PIECE LEADING UP TO THE TIP OF A PROCISE MAX COBLATOR TORE INTO THE SIDE OF THE PATIENT'S SKIN WHERE IT WAS RUBBING IT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24151087 ↗
• MalfunctionMay 13, 2025Overheating of Device; Smoking; Activation Failure; Overheating of Device; Smoking; Activation Failure

  IT WAS REPORTED THAT THE PROCISE MAX COBLATOR WAS OVERHEATING WHEN PLUGGED, IT WAS RELEASING SMOKE. UPON PLUG IN, THE SETTINGS DID NOT COME UP IMMEDIATELY AT 7, 3. AFTER ADJUSTING THE SETTINGS CORRECTLY AND PRIMING THE WAND WITH SALINE, SMOKE IMMEDIATELY APPEARED AT THE WAND TIP. THE WAND WOULD NEITHER ABLATE NOR COAGULATE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015156 ↗
• MalfunctionMay 13, 2025Overheating of Device; Smoking; Activation Failure; Overheating of Device; Smoking; Activation Failure

  IT WAS REPORTED THAT THREE (3) PROCISE MAX COBLATOR WERE OVERHEATING WHEN PLUGGED, THEY WERE RELEASING SMOKE. UPON PLUG IN, THE SETTINGS DID NOT COME UP IMMEDIATELY AT 7, 3. AFTER ADJUSTING THE SETTINGS CORRECTLY AND PRIMING THE WANDS WITH SALINE, SMOKE IMMEDIATELY APPEARED AT THE WAND TIPS. THE WANDS WOULD NEITHER ABLATE NOR COAGULATE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015151 ↗
• MalfunctionDec 6, 2024Device Alarm System; Detachment of Device or Device Component; Device Alarm System; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A T&A, THE PROCISE MAX COBLATOR TIP FELL OFF IN THE PATIENT MOUTH, A LOUD POPPING OCCURRED THEN THE MACHINE ALARMED WITH A DEVICE FAILURE ALERT AND IT WAS NOTED THAT THE TIP HAD BROKEN OFF DURING NORMAL USE. THE PROCEDURE WAS FINISHED WITH A DIFFERENT SURGICAL TECHNIQUE, SUCTION BOVIE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860592 ↗
• InjuryNov 28, 2024Overheating of Device; Suction Problem; Infusion or Flow Problem; Overheating of Device; Suction Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING AN ORAL CAVITY AND OROPHARYNGEAL PROCEDURE, WHILE USING THE PROCISE MAX WAND, THE IRRIGATION SOLUTION SEEMED TO HAVE EXCESSIVELY HEATED UP AND SEEMED TO CAME OUT FAIRLY QUICKLY, CAUSING A PARTIAL THICKNESS WITH BLISTERING/EPIDERMOLYSIS AND BLANCHING ON THE FACE AND TONGUE, SEVERAL CENTIMETERS AWAY FROM THE WAND'S TIP. IMMEDIATELY PRIOR TO NOTICING THE BURN INJURY, THE OPERATING RESIDENT NOTICED THAT FINGERTIPS (WHICH WERE HOLDING THE TONGUE >1 CM AWAY FROM THE COBLATION WAND'S TIP) ABRUPTLY BECAME VERY HOT AT ABOUT THE SAME TIME AS THE COBLATOR SUCTION CLOGGED. THE SETTINGS USED WERE "COBLATE 7/COAG 3". THE BURN SURGERY TEAM EVALUATED THE PATIENT INTRAOPERATIVELY AND DETERMINED THAT A SUPERFICIAL PLASMA FIELD INJURY (CHEMICAL BURN) HAD OCCURRED ON THE LEFT CHEEK SKIN AND VERIFIED THAT AN APPROPRIATE APPROXIMATELY NEUTRAL PH HAD BEEN REACHED AFTER CONTINUED IRRIGATION WITH STERILE WATER, THEY UNROOFED A SMALL AREA WITH BULLOUS CHANGE, THEY COMPLETED THE RESECTION AND CLOSED. THE WOUND WAS CLOSED WITH THE USE OF 4-0 VICRYL SUTURES IN COMBINATION DEEP HORIZONTAL MATTRESS AND SIMPLE INTERRUPTED FASHION SUPERFICIALLY, TAKING CARE TO EVERT ALL EDGES. THE TONGU

  Patient problems: Laceration(s); Partial thickness (Second Degree) Burn

  MAUDE report 20803583 ↗
• MalfunctionJul 10, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TONSILLECTOMY & ADENOIDECTOMY, THE OUTSIDE BOTTOM PORTION OF THE PROCISE COBLATOR II WAND WAS GENERATING HEAT AND CAUSED ABLATION TO UNWANTED AREAS. THE PROCEDURE WAS A COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. THERE WAS NO HARM TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710837 ↗
• InjuryMay 31, 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 WAS BEING USED TO REMOVE THE ADENOID TISSUE AND AT SOME POINT, A RIGHT ORAL COMMISSURE THERMAL INJURY WAS NOT NOTICED (SECOND-DEGREE BURN). NO METAL TO METAL CONTACT WAS MADE DURING THE EVENT AND THE WAND WAS ACTIVATED FOR 10 TO 15 MINUTES. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO SURGICAL DELAY. THE LIP WAS TREATED WITH COOL COMPRESS AND BACITRACIN OINTMENT. THE PATIENT'S LIP IS REPORTED TO BE SWELLING AND PAINFUL.

  Patient problems: Pain; Partial thickness (Second Degree) Burn; Swelling/ Edema

  MAUDE report 19435446 ↗
• MalfunctionMar 15, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP FOR A TONSILLECTOMY PROCEDURE, THE PRECISE MAX WAND WAS FAILING COMING OUT EXTREMELY HOT. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912602 ↗
• MalfunctionMar 14, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE, THE PROCISE MAX WAND WAS OVERHEATING, THE SALINE COMING OUT OF THE DEVICE WAS VERY WARM AND WHEN TESTED OVER A TABLE THE OVERHEATING WAS NOTICED AND DID NOT USE IN PATIENT . THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18909617 ↗
• InjuryFeb 1, 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 DOCTOR USED BY MISTAKE THE PROCISE MAX COBLATOR II, THERE WAS A HEAVY AMOUNT OF INTRAOPERATIVE BLEEDING THAT REQUIRED THE USE OF ADDITIONAL CAUTERY. THE DEVICE ERROR LED TO A DOUBLING OF OPERATIVE TIME AND SIGNIFICANTLY INCREASED INTRAOPERATIVE BLOOD LOSS (2ML). THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE (SUCTION BOVIE). THERE WAS A DELAY LESS THAN 30 MINUTES. PATIENT WAS DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18625870 ↗
• MalfunctionNov 29, 2023Arcing; No Apparent Adverse Event; Arcing; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY, THE PROCISE COBLATOR WAND WAS SPARKING AND WAS NOT ABLATING CORRECTLY. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY OF 5 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18234422 ↗
• MalfunctionJan 2, 2023Suction Problem; Activation Failure; Suction Problem; Activation Failure

  IT WAS REPORTED THAT DURING A TONSILLECTOMY & ADENOIDECTOMY PROCEDURE, THE PROCISE MAX II WAND LOST THE ABILITY TO COBLATE AND SUCTION. THE SUCTION WAS CHECKED AND IT WAS ON FULL SUCTION. THE HANDPIECES TIP WERE CLEANED AND FLUSHED SEVERAL TIMES. THE SETTINGS STARTED AT PRESET # 7 AND 4, WERE INCREASED TO 9 AND 5 THROUGHOUT CASE IN ATTEMPT TO GET THE HANDPIECES TO WORK. THE ISSUES RESULTED IN AN EXTENDED LENGTH OF THE CASE AND BLEEDING FOR THE PATIENT THAT WAS CONTROLLED USING A SUCTION BOVIE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAT 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082731 ↗
• MalfunctionMay 30, 2022Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT DURING SET-UP, THE TIP OF THE PRECISE COLLATOR WAND WAS CRACKED AND LEAKING SALINE. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14541354 ↗
• InjuryAug 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "COBLATION TOTAL TONSILLECTOMY AND ADENOIDECTOMY VERSUS COBLATION PARTIAL INTRACAPSULAR TONSILLECTOMY AND ADENOIDECTOMY IN CHILDREN"; AFTER PROCEDURE WITH A PROCISE MAX WAND, ONE PATIENT HAD POSTOPERATIVE BLEEDING WITH OPERATING ROOM MANAGEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12322401 ↗
• MalfunctionJan 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ENT CASE, WHERE A PROCISE WAND WAS USED, THE PATIENT PRESENTED POST OPERATIVE BLEEDING. IT IS UNKNOWN HOW IT WAS TREATED AND THE CURRENT STATUS OF THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11106018 ↗
• InjuryOct 17, 2020Suction Problem; Suction Problem

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY, IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO SUCCESSFULLY ABLATE DOWN THE TISSUE WITHOUT MASSIVE CLOGGING AND BLEEDING IN ORDER TO REMOVE THE ADENOIDS. THE CASE TOOK OVER 1.5 HOURS WHERE IT SHOULD¿VE TAKEN ABOUT 30 MINUTES. NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10694695 ↗
• InjuryOct 17, 2020Suction Problem; Suction Problem

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY, IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO SUCCESSFULLY ABLATE DOWN THE TISSUE WITHOUT MASSIVE CLOGGING AND BLEEDING IN ORDER TO REMOVE THE ADENOIDS. THE CASE TOOK OVER 1.5 HOURS WHERE IT SHOULD¿VE TAKEN ABOUT 30 MINUTES. NO PATIENT INJURY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10694693 ↗
• MalfunctionJul 22, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE WHEN THE WAND WAS PLUGGED THE GENERATOR COULD NOT GO UP OR DOWN, THE SETTING WAS NOT MOVING, MAKING A NOISE AS WELL WHEN THE WAND WAS ACTIVE IT WAS A STATIC NOISE. THERE WAS A BACKUP DEVICE TO COMPLETE THE PROCEDURE WITH NO DELAY OR FURTHER COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311820 ↗
• InjuryJun 29, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE BURNS AROUND THE LIP AND MOUTH AREA WHERE THE MOUTH GAG WAS PLACED TO PERFORM THE PROCEDURE. THERE WAS NO DELAY REPORTED.

  Patient problems: Burn, Thermal

  MAUDE report 7651696 ↗
• MalfunctionJun 21, 2018Device Operates Differently Than Expected

  IT WAS REPORTED BY THE CUSTOMER THAT THE DEVICE PRESENTED HEATING. OCCURRED DURING PROCEDURE. NO DELAY WAS REPORTED, A BACK-UP WAS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7626250 ↗
• MalfunctionJun 4, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT 7 DAYS AFTER AN ADENOID PROCEDURE, A (B)(6) PATIENT IS EXPERIENCING PAIN. THE PATIENT IS NOT SLEEPING, NOT EATING, THE THROAT IS RED AND IS TAKING PAIN MEDICINES REGULARLY.

  Patient problems: Feeding Problem; Pain; Sleep Dysfunction

  MAUDE report 7564354 ↗
• MalfunctionMay 31, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A (B)(6) IS EXPERIENCING PAIN 7 DAYS AFTER PROCEDURE. NO SLEEPING, NO EATING, AND TAKING PAIN MEDS REGULARLY. COMPLAINING OF SORE THROAT BUT NO REDNESS YET. THIS IS ALL POST-OPERATIVE.

  Patient problems: Pain

  MAUDE report 7556935 ↗
• MalfunctionMay 15, 2018Smoking; Suction Problem

  IT WAS REPORTED THAT THE WAND WAS LACKING OF SUCTION AND WHEN THEY TRIED TO REMOVE IT THE WAND STARTED SMOKING ON THE OPERATING FIELD. PROCEDURE WAS COMPLETED WITH A BACK-UP DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7515503 ↗
• MalfunctionMar 19, 2018Sparking

  IT WAS REPORTED THAT WAND WAS SPARKING OUTSIDE OF THE PATIENT. DEVICE DID NOT OVERHEAT. NO PATIENT OR USER INJURY WAS REPORTED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO MAJOR DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7349613 ↗