Coblation EICA7070-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00817470004243), received between Oct 30, 2019 and Feb 18, 2025 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Fire; Fire

  IT WAS REPORTED THAT, DURING A BILATERAL EAR TUBE REPLACEMENT, MICRODIRECT LARYNGOSCOPY, BRONCHOSCOPY & SUPRAGLOTTOPLASTY PROCEDURE, WHILE THE PATIENT HAD THE ET TUBE, SCOPE AND HAD USED A PROCISE COBLATOR II FOR 5 MINUTES IN THE AIRWAY, THE MOUTH CAUGHT INTO FLAMES. A "FIRE-BALL" WAS NOTED WITHIN THE ENDOTRACHEAL TUBE (POSITIONED IN THE OROPHARYNX). ALL TOOLS WERE IMMEDIATELY REMOVED FROM THE PATIENT'S MOUTH/AIRWAY AND SALINE WAS POURED ONTO SITE. WHEN THE PATIENT WAS STABILIZED, THE AREA INVOLVED WAS FLUSHED OUT WITH SALINE. THE EVENT TERMINATED THE PROCEDURE, NO FURTHER COBLATION WAS DONE. THERE WAS NO DELAY SINCE THE SURGEON WAS FINISHING THE CASE WHEN THE INCIDENT HAPPENED. THE PATIENT REQUIRED RE-INTUBATION WITH A NEW ET TUBE AND BRONCHOSCOPY WAS COMPLETED FOR AIRWAY ASSESSMENT. THE PATIENT DEVELOPED SIGNIFICANT AIRWAY BURNS AND REMAINED INTUBATED FOR MULTIPLE DAYS POST-INCIDENT.

  Patient problems: Burn(s)

  MAUDE report 21400312 ↗
• MalfunctionMar 29, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, A THE PROCISE'S ELECTRODE FELL OFF EXTERNAL TO THE PATIENT WHEN TRYING TO CLEAN IT. THE SURGERY WAS RESUMED, AFTER A 5 MINUTES DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639910 ↗
• MalfunctionDec 19, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT, DURING A SUPRAGLOTTOPLASTY, THE TIP OF THE PROCISE COBLATOR II WAND WAS MISSING AN ELECTRODE. IT IS NOT CERTAIN WHEN THE ELECTRODE WENT MISSING, HOWEVER, IT DID NOT FALL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED AFTER A 1-MINUTE DELAY USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003148 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT, THE PIECE OF THE TIP OF PROCISE LW COBLATOR II, BROKE OFF. IT IS UNKNOWN WHEN THE EVENT OCCURRED RELATIVE TO SURGERY, HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540927 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿*MINIMALLY INVASIVE PROCEDURE FOR DIAGNOSIS AND TREATMENT OF VALLECULAR CYSTS IN CHILDREN: REVIEW OF 156 CASES.¿, AFTER SURGERY WITH A "PROCISE LW COBLATOR II WAND" A PATIENT HAD A RECURRENT CYST. THE COMPLICATION WAS TREATED WITH AN ADDITIONAL SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s)

  MAUDE report 12111542 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿SURGICAL MANAGEMENT OF AIRWAY STENOSIS BY RADIOFREQUENCY COLLATION¿; AFTER SURGERY WITH A "PROCISE LW COLLATOR II WAND" A PATIENT HAD RECURRENT TRACHEAL STENOSIS. THE COMPLICATION WAS TREATED WITH AN ADDITIONAL OBLATION SURGERY. THE PATIENT REQUIRED FURTHER TREATMENT WITH A DILATION BALLOON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Restenosis

  MAUDE report 12110299 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿SURGICAL MANAGEMENT OF AIRWAY STENOSIS BY RADIOFREQUENCY COBLATION¿; AFTER SURGERY WITH A "PROCISE LW COBLATOR II WAND" A PATIENT HAD RECURRENT TRACHEAL STENOSIS. THE COMPLICATION HAS BEEN TREATED WITH ADDITIONAL COBLATION SURGERIES. THE PATIENT REQUIRED FURTHER TREATMENT WITH BALLOON DILATION, MITOMYCIN C INJECTION AND STENTING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Restenosis

  MAUDE report 12110186 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿SURGICAL MANAGEMENT OF AIRWAY STENOSIS BY RADIOFREQUENCY COBLATION¿; AFTER SURGERY WITH A "PROCISE LW COBLATOR II WAND" A PATIENT HAD RECURRENT TRACHEAL STENOSIS. THE COMPLICATION HAS BEEN TREATED WITH COBLATION SURGERIES. THE PATIENT REQUIRED FURTHER TREATMENT WITH A DILATION BALLOON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Restenosis

  MAUDE report 12110125 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿SURGICAL MANAGEMENT OF AIRWAY STENOSIS BY RADIOFREQUENCY COBLATION¿; AFTER SURGERY WITH A "PROCISE LW COBLATOR II WAND" A PATIENT HAD RECURRENT SUBGLOTTIC STENOSIS. THE COMPLICATION HAS BEEN TREATED WITH 3 COBLATION SURGERIES. THE PATIENT REQUIRED FURTHER TREATMENT WITH A DILATION BALLOON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Restenosis

  MAUDE report 12110115 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW ¿*MINIMALLY INVASIVE PROCEDURE FOR DIAGNOSIS AND TREATMENT OF VALLECULAR CYSTS IN CHILDREN: REVIEW OF 156 CASES.¿, AFTER SURGERY WITH A "PROCISE LW COBLATOR II WAND" A PATIENT HAD A RECURRENT CYST. THE COMPLICATION WAS TREATED WITH AN ADDITIONAL SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Cyst(s)

  MAUDE report 12109101 ↗
• 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 ¿LOW-TEMPERATURE RADIOFREQUENCY COBLATION REDUCES TREATMENT INTERVAL AND POST-OPERATIVE PAIN OF LARYNGOTRACHEAL RECURRENT RESPIRATORY PAPILLOMATOSIS¿, AN UNSPECIFIED NUMBER OF PATIENTS WERE RE-OPERATED AFTER THE PROCEDURE IN WHICH A PROCISE LW WAS USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12104941 ↗
• 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 ¿LOW-TEMPERATURE RADIOFREQUENCY COBLATION REDUCES TREATMENT INTERVAL AND POST-OPERATIVE PAIN OF LARYNGOTRACHEAL RECURRENT RESPIRATORY PAPILLOMATOSIS.¿, THREE PATIENTS DEVELOPED VOCAL CORD ADHESIONS AFTER PROCEDURES IN WHICH A PROCISE LW WAS USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s)

  MAUDE report 12104869 ↗
• 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 ¿LOW-TEMPERATURE RADIOFREQUENCY COBLATION REDUCES TREATMENT INTERVAL AND POST-OPERATIVE PAIN OF LARYNGOTRACHEAL RECURRENT RESPIRATORY PAPILLOMATOSIS.¿, ONE PATIENT PRESENTED WITH ASPHYXIA AFTER THE PROCEDURE IN WHICH A PROCISE LW WAS USED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Respiratory Insufficiency

  MAUDE report 12104868 ↗
• InjuryFeb 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE RESECTION PROCEDURE OF THE LARYNX LESION USING THE PROCISE LW WAND, AN LW RADIOFREQUENCY TIP WAS USED, AFTER 5 MIN OF USE THE ELECTRODE BROKE OFF AND THE TIP STOPPED WORKING, DID NOT COAGULATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 30 MINUTES OR LESS USING A BACK-UP DEVICE. 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 11345650 ↗
• InjuryDec 23, 2020Material Separation; Connection Problem; Material Separation; Connection Problem

  IT WAS REPORTED THAT DURING A PALATINE TONSIL RESECTION PROCEDURE, WHEN THE TISSUE RESECTION WAS STARTED THERE WAS SOME BLEEDING BUT THE PROCISE WAS NOT COAGULATING AND IT WAS FOUND THAT THE ELECTRODE WAS INCOMPLETE DUE TO THE INCREASED LEVEL OF BLEEDING IN THE PATIENT. THE ELECTRODE WAS WORN AND FELT INSIDE THE PATIENT'S ANATOMY. AT THE BEGINNING IT WAS A NORMAL LEVEL OF BLEEDING BUT DURING THE NOVELTY THE LEVEL OF BLEEDING INCREASED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY GREATER THAN 30MIN, USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11068986 ↗
• MalfunctionOct 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE SURGERY THE DEVICE BROKE, WHERE THE HEAD IS (THE END OF THE TIP). IT IS UNKNOWN IF THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9257896 ↗