Coblation EIC8872-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00817470000368), received between Dec 6, 2017 and May 6, 2026 — classified as 18 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Peeled/Delaminated

  IT WAS REPORTED THAT, DURING A T&A PROCEDURE, THERE WAS A CRACK ON THE PROCISE XP COBLATOR II WHEN IT WAS OPENED. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE.. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25101160 ↗
• MalfunctionFeb 22, 2026Fracture

  IT WAS REPORTED THAT DURING A NASAL POLYP SURGERY, IT WAS NOTICED THAT THE PROCISE XP COBLATOR II WAND'S METAL ELECTRODE WIRE FRACTURED. ALL THE FRACTURE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410865 ↗
• MalfunctionFeb 4, 2026Fracture; Melted

  IT WAS REPORTED THAT, DURING A TONSILLECTOMY, THE ELECTRODE WIRE OF TWO (2) PROCISE XP COBLATOR II MELTED AND FRACTURED. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261066 ↗
• MalfunctionSep 28, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ENT SURGERY, IT WAS NOTICED THAT THE METAL WIRE OF A PROCISE XP 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 23163893 ↗
• MalfunctionSep 22, 2025Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT DURING AN ADENOID BODY RESECTION SURGERY, TWO ELECTRODES OF THE PROCISE XP COBLATOR II WERE FOUND TO BE BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY; HOWEVER, THE PROCEDURE WAS COMPLETED USING AN EQUIVALENT S+N BACKUP AFTER WOUND EXPLORATION AND FLUSHING. THERE WAS A RISK OF SURGICAL TISSUE LOCATION IN PATIENTS WITH BURNS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23106810 ↗
• MalfunctionJun 26, 2025Melted; Melted

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE METAL ELECTRODE WIRE OF THE PROCISE XP FUSED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340520 ↗
• MalfunctionJun 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE PRECISE XP WAS STUCK, AND IT COULD NOT BE USED NORMALLY AFTER CLEANING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22303855 ↗
• MalfunctionDec 23, 2024Break; Failure to Deliver Energy; Break; Failure to Deliver Energy

  IT WAS REPORTED THAT, DURING AN ADENOIDECTOMY PROCEDURE, THE METAL WIRE OF THE PROCISE XP COBLATOR WAND BROKE AND COULD NOT GENERATE PLASMA. 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 21000704 ↗
• MalfunctionDec 6, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT DURING A NASAL SKULL BASE SURGERY, TWO METAL WIRES OF THE PROCISE COBLATOR II WAND BROKE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860528 ↗
• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT DURING A NASAL SKULL BASE SURGERY, ALL THREE ELECTRODE WIRES OF THE PROCISE WAND WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20839118 ↗
• MalfunctionDec 3, 2024Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT DURING A NASAL SKULL BASE SURGERY, TWO ELECTRODES WIRES ON THE PRECISE WAND WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20838980 ↗
• MalfunctionDec 3, 2024Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT DURING A TONSILLECTOMY + ADENOIDECTOMY, THE METAL WIRE OF THE PROCISE WAND BROKE. THERE WAS A BACK UP DEVICE AVAILABLE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20838976 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN NASAL SKULL BASE TUMOR OPERATION, THE WIRE OF THE PROCISE COBLATOR II FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792387 ↗
• MalfunctionNov 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN NASAL SKULL BASE TUMOR OPERATION, THE WIRE OF THE PROCISE COBLATOR II FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS NO DELAY. NONE OF THE BROKEN PIECES FELL INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791778 ↗
• MalfunctionSep 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE PROCISE COBLATOR WAND WAS BROKEN. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315790 ↗
• MalfunctionSep 17, 2024Break; Arcing; Break; Arcing

  IT WAS REPORTED THAT DURING TONSILLECTOMY + ADENOIDECTOMY PROCEDURE, A TOTAL OF THREE PROCISE XP WAND'S METAL WIRES SPARKED AND BROKE OFF. THE SURGERY WAS COMPLETED USING A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT STATUS IS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236562 ↗
• MalfunctionSep 10, 2024Break; Material Erosion; Break; Material Erosion

  IT WAS REPORTED THAT, DURING TONSILLECTOMY + ADENOIDECTOMY PROCEDURE, THE PROCISE XP WAND'S METAL WIRE BROKE AND THE TISSUE COULD NOT BE CUT. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT BY USING SUCTION. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180914 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ENT SURGERY THE METAL ELECTRODE OF THE PROCISE WAND WIRE OF THE WAND BROKE. THERE WAS A BACK UP DEVICE AVAILABLE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20082473 ↗
• MalfunctionAug 27, 2024Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING THE START OF A TONSILLECTOMY, THE TIP OF THE PROCISE XP PRODUCED MORE THAN USUAL SMOKE; THE HAND PIECE BECOME HOT AND THE SUCTION TUBING FROM THE HANDPIECE WAS OBSERVED TO BE HOT WHEN THE HANDPIECE WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20076702 ↗
• MalfunctionAug 14, 2024Overheating of Device; Arcing; Intermittent Energy Output; Overheating of Device; Arcing; Intermittent Energy Output

  IT WAS REPORTED THAT, DURING TONSILLECTOMY + ADENOIDECTOMY PROCEDURE, THE PROCISE XP WAND HAD AN ELECTRICAL SPARK AND OVERHEATED. SURGERY WAS COMPLETED WITH A COMPETITOR DEVICE, INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987865 ↗
• MalfunctionJul 31, 2024Activation Failure; Activation Failure

  IT WAS REPORTED DURING A PROCEDURE THE PROCISE COBLATOR WAND WAS UNABLE TO ACTIVATE. THERE WAS A BACK UP DEVICE AVAILABLE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19877114 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ADENOIDECTOMY, THE TIP OF THE PROCISE XP WAND WAS FOUND TO BE BROKEN INTO PIECES. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727065 ↗
• MalfunctionApr 16, 2024Break; Material Erosion; Break; Material Erosion

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, AFTER OPENING THE PRECISE WAND PACKAGE AND USING IT FOR 5 MINUTES, THE ELECTRODE WIRE BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122233 ↗
• MalfunctionMar 21, 2024Fire; Device Emits Odor; Smoking; Fire; Device Emits Odor; Smoking

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SINUS SURGERY, THE PROCISE XP COBLATOR II IGNITED (SET ON FIRE), SMOKED AND HAD A BURNING SMELL DURING THE IN VITRO TRIAL WHEN THE DEFAULT SETTINGS WERE 8 AND 4. LATER, THE SETTINGS WERE ADJUSTED TO 6 AND 3 AND THE PROCISE XP NO LONGER IGNITED BUT STILL SMOKED AND HAD THE STICKY SMELL, MAKING IT DIFFICULT TO CUT TISSUE. THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT 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 18952206 ↗
• MalfunctionJan 23, 2024Circuit Failure; Arcing; Circuit Failure; Arcing

  IT WAS REPORTED THAT DURING SET UP, THE PROCISE COBLATOR WAND HAD A CIRCUIT FAILURE AND THE WAND SPARKED. THERE WAS A BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566445 ↗