COBLATION EICA8872-01 (UDI 00817470003727)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00817470003727), received between Sep 28, 2017 and Apr 19, 2026 — classified as 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2026Break; Degraded

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, ONE PROCISE XP ELECTRODES BURNED OFF OR BROKE; THERE WAS ONLY ONE HORIZONTAL METAL LINE NOTED AND TWO METAL HORIZONTAL LINE WAS MISSING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921331 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING 24 HOURS AFTER THE SURGERY WITH THE PROCISE XP COBLATOR WAND AND HAD TO RETURN TO SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24722552 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING 24 HOURS AFTER THE SURGERY WITH THE PROCISE XP COBLATOR WAND AND HAD TO RETURN TO SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24644287 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AFTER AN ENT PROCEDURE, THE PROCISE XP COBLATOR II WAND DID NOT PERFORM AS EXPECTED DUE THAT PATIENT EXPERIENCED BLEEDING AT SOME POINT DURING THE FIRST 24 HOURS. THE PATIENT HAD TO RETURN TO THE ER FOR TREATMENT AND WAS GIVEN MEDICATION TO CONTROL THE BLEEDING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21668861 ↗
• MalfunctionAug 16, 2023Break; Break

  IT WAS REPORTED THAT DURING A TONSILLECTOMY AND ADENOIDECTOMY PROCEDURE, THE PRONGS OF THE PROCISE COBLATOR II WAND TIP BROKE IN THE MIDDLE OF THE CASE. 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 17558725 ↗
• InjuryMay 31, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A TONSILLECTOMY, THE SURGEON NOTICED THAT THE PROCISE XP COBLATOR II WAND WAS NO LONGER WORKING, THUS, THE SURGEON INSPECTED THE TIP WITH A MAGNIFYING SURGICAL LOPS AND STATED THAT THE MIDDLE COIL/WIRE WAS MISSING. IT WAS STATED THAT THE PIECE WAS LEFT INSIDE OF THE PATIENT. 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: Foreign Body In Patient

  MAUDE report 17031654 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SURGERY WITH A PROCISE WAND, A 6 YEAR OLD CHILD PASSED AWAY DUE TO POST OP BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16387406 ↗
• InjuryJan 19, 2023Activation Failure; Suction Failure; Activation Failure; Suction Failure

  IT WAS REPORTED THAT DURING A TONSIL AND ADENOID PROCEDURE THE PROCISE XP II DID NOT BURN WELL AND THERE WERE LOTS OF BLEEDING, AND IT ALSO KEPT GETTING CLOGGED. THE BLEEDING WAS STOPPED BY THE DOCTOR WHEN A NEW WAND WAS USED. 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 16206873 ↗
• MalfunctionJan 2, 2023Activation Failure; Suction Failure; Activation Failure; Suction Failure

  IT WAS REPORTED THAT DURING A TONSILLECTOMY & ADENOIDECTOMY PROCEDURE, TWO (2) PROCISE XP COBLATOR WANDS 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 16082720 ↗
• InjuryOct 31, 2022Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A LITTLE LIP BURN WHEN USING THE PROCISE COBLATOR II. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

  Patient problems: Burn(s)

  MAUDE report 15698461 ↗
• InjuryOct 26, 2022Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE USING A PROCISE XP WAND, THE COAGULATION FUNCTION WAS NOT WORKING EFFECTIVELY AND PRODUCING THE COAG RESULT THAT IS NORMALLY PRODUCED. INTRA-OPERATIVELY, IT WAS NOTICED THAT THERE WAS A VISIBLE BURN ON THE LOWER RIGHT SIDE OF THE LIP. THE WOUND WAS NOT STAGED. IN RECOVERY, THE TISSUE WAS INTACT, GREY-WHITE COLOR, NO DRAINAGE. THE BURN WAS TREATED WITH VASELINE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 15676297 ↗
• InjuryOct 26, 2022Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE USING A PROCISE XP WAND, THE COAGULATION FUNCTION WAS NOT WORKING EFFECTIVELY AND PRODUCING THE COAG RESULT THAT IS NORMALLY PRODUCED. INTRA-OPERATIVELY, IT WAS NOTICED THAT THERE WAS A VISIBLE BURN ON THE LOWER RIGHT SIDE OF THE LIP. THE WOUND WAS NOT STAGED. IN RECOVERY, THE TISSUE WAS INTACT, GREY-WHITE COLOR, NO DRAINAGE. THE BURN WAS TREATED WITH VASELINE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 15676251 ↗
• MalfunctionSep 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TONSILLECTOMY A COBLATOR II WAS NOT WORKING, THE THREE WIRES WERE NOT INTACT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. THE WIRES DID NOT BREAK OFF INSIDE THE PATIENT, THEREFORE THERE WAS NO NEED TO BE RETRIEVED FROM THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. PRELIMINARY RESULTS OF INVESTIGATION FOUND THAT THE ELECTRODE WAS COMPLETELY DETACHED WHICH CAUSED THAT THE WAND COULD NOT BE ABLE TO GENERATE PLASMA AND COAGULATION DUE TO DETACHED ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513054 ↗
• InjuryOct 26, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY PROCEDURE, THE ELECTRODES OF THE "PROCISE XP WAND" BURNT OUT FAST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT VISUAL INSPECTION OF THE DEVICE SHOWED DETACHMENT OF ONE OF THE ELECTRODES AND THIS IS A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10738561 ↗
• MalfunctionMar 20, 2018Device Emits Odor; Smoking

  IT WAS REPORTED THAT THE MACHINE "SMELT FUNNY" IN SURGERY AND THE WAND WAS SMOKING/STEAMING ABNORMALLY. ALL SYSTEM EQUIPMENT ASSOCIATED WITH THE CASE IS BEING RETURNED FOR EVALUATION. PROCEDURE WAS COMPLETED USING A COMPETITIVE DEVICE (BOVIE-CAUTERY). NO PATIENT INJURY OR OTHER COMPLICATIONS REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7353612 ↗
• MalfunctionJan 5, 2018Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LINGUAL TONSILLECTOMY WHEN THE WIRE ON THE WAND BROKE. PATIENT WAS CLOSELY MONITORED AND PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THIS CAME FROM VOLUNTARY MEDWATCH DIRECTLY FROM FDA MW5073732. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7170170 ↗
• MalfunctionJan 5, 2018Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INGUINAL AND PALATINE TONSILECTOMY AND AT THE END OF THE PROCEDURE IT WAS NOTICED THAT ONE OF THE THREE WIRES OF THE WAND WAS BROKEN. PATIENT WAS ADMITTED TO THE HOSPITAL OVERNIGHT TO BE CLOSELY MONITORED FOR ANY POST-OPERATIVE COMPLICATIONS. HE WAS SUBSEQUENTLY DISCHARGED. BASED ON THE CURRENT AVAILABLE INFORMATION NO SERIOUS INJURY COULD BE CONFIRMED. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7168503 ↗
• MalfunctionSep 28, 2017Sparking

  IT WAS REPORTED THAT THE PROCISE COBLATOR WAS SPARKING. A BACK-UP DEVICE WAS AVAILABLE AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6901100 ↗