Coblation EIC7070-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00817470000443), received between Sep 4, 2018 and May 1, 2026 — classified as 1 death, 7 injuries, 20 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 1, 2026Material Separation

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE ELECTRODE FELL OFF (2) TWO PROCISE WANDS. THEY HAD TO DO AN X-RAY TO ENSURE THERE WAS NO METAL INSIDE OF THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP.NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062318 ↗
• MalfunctionNov 25, 2025Arcing; Activation Failure; Arcing; Activation Failure

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, THE PROCISE COBLATOR WAND DID NOT ABLATE AND SPARKED. THE PROCEDURE WAS RESUMED AFTER A SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE PATIENT WAS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641148 ↗
• MalfunctionNov 15, 2025Failure to Deliver Energy; Detachment of Device or Device Component; Failure to Deliver Energy; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ENDOSCOPIC RESECTION OF RECURRENT LARYNGEAL PAPILLOMA, THE METAL WIRE OF THE TIP OF A PROCISE LW WAND HAD FALLEN OFF AND THERE WAS NO ENERGY OUTPUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23564231 ↗
• MalfunctionSep 23, 2025Break; Material Erosion; Break; Material Erosion

  IT WAS REPORTED THAT, DURING AN ENT SURGERY, IT WAS NOTICED THAT THE METAL WIRE OF A PROCISE LW WAND BROKE. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23124695 ↗
• MalfunctionSep 11, 2025Break; Failure to Deliver Energy; Suction Problem; Break; Failure to Deliver Energy; Suction Problem

  IT WAS REPORTED THAT, DURING A LARYNGEAL PROCEDURE, THE PROCISE COBLATOR COULD NOT DO SUCTION AFTER ABLATION. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031811 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE METAL WIRE OF THE PROCISE COBLATOR BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED WITH A SN BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954593 ↗
• MalfunctionDec 23, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A LARYNGEAL SURGERY, THE PROCISE WAND HAD NOT REACTION WHEN CONNECTED TO THE CONTROLLER. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21006435 ↗
• MalfunctionSep 18, 2023Arcing; Arcing

  IT WAS REPORTED THAT DURING SET UP, IT WAS FOUND THAT THE PROCISE WAND SPARKED. THERE WAS A BACK-UP DEVICE AVAILABLE AND NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770319 ↗
• MalfunctionSep 18, 2023Arcing; Arcing

  IT WAS REPORTED THAT BEFORE AN ENT SURGERY, A PROCISE COBLATOR II HAD AN ELECTRIC SPARK. THERE WAS A BACK-UP DEVICE AVAILABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765981 ↗
• MalfunctionJul 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LARYNGEAL CANCER SURGERY, THE ELECTRODE OF THE PROCISE LW WAND FELL OF AFTER 15 MINUTES OF USE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397350 ↗
• MalfunctionMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A LARYNGEAL CANCER SURGERY, THE TIP OF THE ELECTRODE FELL OF THE PROCISE COBLATOR'S WAND, HOWEVER, IT DID NOT FALL INSIDE THE PATIENT. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863327 ↗
• MalfunctionApr 26, 2023Melted; Activation Failure; Melted; Activation Failure

  IT WAS REPORTED THAT DURING A LARYNGEAL SURGERY, THE COBLATION WAND FAILED TO COAGULATE AND IT PRESENTED THREE METAL WIRES FUSED, THE SETTING USED ON THE CONTROLLER WAS ABLATION: 7; COAGULATION: 3. THE PROCEDURE WAS COMPLETED BY CHANGING THE SURGICAL TECHNIQUE FOR ELECTROCOAGULATION FOR HOMEOSTASIS, AND WITH A 31-MINUTE SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812625 ↗
• InjuryApr 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE TIP OF THE COBLATION WAND FELL OFF AND GOT STUCK INTO THE PATIENT'S TISSUE. THE PIECE WAS REMOVED EVENTUALLY BY USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743410 ↗
• MalfunctionJan 16, 2023Break; Break

  IT WAS REPORTED THAT DURING A ENT THE PROCISE LW WAND HEAD BROKE .THE DEVICE DID NOT BREAK INTO PIECES OR FRAGMENTS INSIDE THE PATIENT.THE PATIENT COULD NOT STOP BLEEDING. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16177478 ↗
• InjurySep 19, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE ELECTRODE OF THE PROCISE WAND BROKE OFF, THE BROKEN PARTS WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15444032 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW THE CLINICAL EFFECTIVENESS AND SAFETY OF LOW -TEMPERATURE PLASMA RADIOFREQUENCY ABLATION OF MICRO -SUPPORTED LARYNGOSCOPE IN THE TREATMENT OF EARLY GLOTTIC LARYNGEAL CARCIN, 1 PATIENT HAD A LUNG INFECTION AFTER A MICROSUPPORTED LARYNGOSCOPE CRYOGENIC PLASMA RADIOFREQUENCY ABLATION PROCEDURE USING A PROCISE COBLATOR WAND. IT IS UNKNOWN HOW WAS THE EVENT TREATED/RESOLVED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15008490 ↗
• MalfunctionJun 8, 2022Break; Failure to Deliver Energy; Break; Failure to Deliver Energy

  IT WAS REPORTED THAT, DURING SET UP FOR AN ENT PROCEDURE, THE PROCISE COBLATOR BROKE OFF AND WAS NOT CREATING PLASMA. ANOTHER SURGICAL TECHNIQUE WAS USED AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630146 ↗
• DeathApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW THE MANAGEMENT OF INFANTILE TONGUE BASE CYST WITH LARYNGOMALACIA, 5 PATIENTS HAD COMPLICATIONS AFTER A LARYNGOMALACIA PROCEDURE USING A PROCISE LW COBLATION WAND. 1 PATIENT HAD A DISCONNECTION OF THE TUBE ON THE 1ST DAY AFTER THE OPERATION, AND WAS NOT REINSERTED BECAUSE OF STABLE BREATHING AND DISAPPEARANCE OF STRIDOR AT THAT TIME, LARYNGEAL STRIDOR APPEARED AGAIN ON THE 5TH DAY AFTER THE OPERATION, IT REQUIRED A REVISION SURGERY 1 MONTH AFTER THE OPERATION AND WAS INTUBATED FOR 5 DAYS AND RECOVERED WELL, 3 PATIENTS HAD AN INTUBATION TIME EXTENDED TO 8 DAYS DUE TO PNEUMONIA, 1 OTHER PATIENT WAS EXTUBATED POSTOPERATIVELY, AND ON THE FIRST POSTOPERATIVE DAY, LARYNGEAL STRIDOR REAPPEARED, AND LARYNGOSCOPY REVEALED EPIGLOTTIS INVERSION. THE PATIENT WAS INTUBATED IN THE ICU. THE TUBE WAS DISCONNECTED ON THE 4TH DAY AND THE PATIENT DIED. THE REASON MAY BE THAT THE TRACHEAL TUBE WAS MISTAKENLY INSERTED INTO THE SURGICAL AREA OF THE LINGUAL ROOT CYST DURING EMERGENCY INTUBATION DUE TO THE EDEMA AND UNCLEAR STRUCTURE OF THE SUPRAGLOTTIC TISSUE AFTER COBLATION. THIS RESULTED IN SUBCUTANEOUS EMPHYSEMA IN THE NECK CAUSED BY THE AIR FLOW THROUGH THE AN

  Patient problems: Pneumonia; Respiratory Arrest; Upper Respiratory Tract Injury; Wheezing

  MAUDE report 14004862 ↗
• MalfunctionFeb 3, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LARYNGEAL SURGERY, THE PROCISE COBLATOR II WAND WAS NOT ABLE TO GENERATE PLASMA, DUE TO THE DETACHMENT OF THE ELECTRODE. THE DETACHED ELECTRODE DID NOT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13445355 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿COLD-PLASMA POSTERIOR ARYTENOIDOCHORDECTOMY FOR CHRONIC PARALYTIC LARYNGOSTENOSIS¿, AFTER AN ENT PROCEDURE WITH A "PROCISE LW COBLATOR II WAND", A PATIENT DEVELOPED A SCAR MEMBRANE. THE COMPLICATION WAS TREATED WITH A SECOND SURGERY TO REMOVE THE SCAR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Scar Tissue

  MAUDE report 12105076 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿*COLD-PLASMA POSTERIOR ARYTENOIDOCHORDECTOMY FOR CHRONIC PARALYTIC LARYNGOSTENOSIS¿, AFTER AN ENT PROCEDURE WITH A "PROCISE LW COBLATOR II WAND", A PATIENT EXPERIENCED INSUFFICIENT LATERAL POSITION OF THE FOLD IN THE LEFT THIRD OF THE VOCAL FOLD DUE TO CICATRICIAL CHANGES. THE COMPLICATION WAS TREATED WITH A SECOND SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Scar Tissue

  MAUDE report 12105064 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿COLD-PLASMA POSTERIOR ARYTENOIDOCHORDECTOMY FOR CHRONIC PARALYTIC LARYNGOSTENOSIS¿, DURING AN ENT PROCEDURE WITH A "PROCISE LW COBLATOR II WAND", LARYNX MUSCLE TWITCHING WAS NOTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Twitching

  MAUDE report 12105048 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿*COLD-PLASMA POSTERIOR ARYTENOIDOCHORDECTOMY FOR CHRONIC PARALYTIC LARYNGOSTENOSIS¿, AFTER AN ENT PROCEDURE WITH A "PROCISE LW COBLATOR II WAND", A PATIENT HAD SHORTNESS OF BREATH & DISCOMFORT 2 MONTHS POST-OP, A GRANULOMA WAS FOUND ON THE LEFT VOCAL FOLD. THE COMPLICATION WAS TREATED WITH A SECOND SURGERY TO REMOVE IT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Granuloma

  MAUDE report 12104991 ↗
• MalfunctionApr 13, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING LARYNGEAL TUMOR SURGERY THE PROCISE COBLATOR WAND DID NOT PRODUCE PLASMA AND THE CONTROLLER WAS INDICATING THAT THE WAND WAS ACTIVATED WITH AUDIBLE TONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE, THERE WAS NOT A SIGNIFICANT DELAY. 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 11654242 ↗
• MalfunctionMar 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A LARYNGEAL SURGERY, THE ELECTRODE ON THE "PROCISE LW COBLATOR II WAND" FELL OFF OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE WITH A DELAY GREATER THAN 30MIN. 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 11580353 ↗