Coblation EIC7071-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00817470000597), received between Jul 9, 2019 and Sep 25, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2025Leak/Splash; Overheating of Device; Leak/Splash; Overheating of Device

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, IT WAS NOTICED THAT THE PROCISE MINI COBLATOR WAS LEAKING WATER AND THE WATER TEMPERATURE WAS TOO HIGH. THE WATER FLEW OUT SMOKING AND THE WAND WAS OVERHEATED, BUT THERE WAS NO ALARM. THE ENT PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE (USING A LASER). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23143971 ↗
• MalfunctionJun 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A TRACHEAL COBLATION FOR SUPRASTOMAL GRANULOMA EXCISION, A BIT OF PLASTIC SHEATHING ADJACENT TO THE CRESCENT-SHAPED SUCTION OF THE PROCISE COBLATOR II CAME OFF. THE USED SETTINGS WERE THE STANDARD 7/3 AT THE TIME OF THE MALFUNCTION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22142405 ↗
• MalfunctionMay 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE PLASTIC COVER OF THE PROCISE WAND BROKE OFF DURING USE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING THE SUCTION OF THE WAND. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. 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 22107585 ↗
• MalfunctionMay 13, 2024Break; Arcing; Material Deformation; Break; Arcing; Material Deformation

  IT WAS REPORTED THAT THE PROCISE MINI WAND WAS BENT, DEFORMED, AND BROKEN LEADING TO INTERMITTENT ARCING IN THE BROKEN PART. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19306413 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CORDECTOMY PROCEDURE WAS PERFORMED WITH THE PROCISE MINI LARYNGEAL WAND, THE PATIENT REQUIRED LATE HOSPITALIZATION DUE TO SEVERE EDEMA OF THE LARYNX. INTRAOPERATIVELY, ABLATION AND COAGULATION WORKED CORRECTLY. PATIENT OUTCOME WAS GOOD. PATIENT RECOVERED SATISFACTORILY.

  Patient problems: Swelling/ Edema

  MAUDE report 12484785 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A CORDECTOMY PROCEDURE WAS PERFORMED WITH THE PROCISE MINI LARYNGEAL WAND, THE PATIENT REQUIRED LATE HOSPITALIZATION DUE TO SEVERE EDEMA OF THE LARYNX. INTRAOPERATIVELY, ABLATION AND COAGULATION WORKED CORRECTLY. PATIENT OUTCOME WAS GOOD. PATIENT RECOVERED SATISFACTORILY.

  Patient problems: Swelling/ Edema

  MAUDE report 12483868 ↗
• InjuryDec 28, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A VOCAL CORD POLYP SURGERY, THE WIRE OF THE PRECISE MINI WAND ELECTRODE FELL OFF AND BREAK INSIDE THE PATIENT ALL THE PIECES WERE REMOVED USING TWEEZER . THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE, WITHOUT A SIGNIFICANT DELAY. 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 11080366 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LARYNGEAL PROCEDURE, THE PROCISE WAND STOPPED WORKING INTRA-OPERATIVELY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED USING A REGULAR CAUTERY. 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 11036933 ↗
• MalfunctionJul 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, WHEN THE WAND WAS OPENED AND BEING PRIMED WITH 0.9% NACL, THE IRRIGATION TUBING WAS LEAKING, AS THIS HAD A PINPRICK HOLE. A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED FOR MORE THAN HALF-AN-HOUR. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8774292 ↗