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Coblation EIC8875-01Recalls & reported problems

Smith & Nephew, Inc. · ENT COBLATOR II, PROCISE EZ VIEW · Class 2

Quick summary

This Smith & Nephew Procise EZ View wand is an electrosurgical handpiece used in ENT procedures such as tonsil and adenoid surgery to cut and coagulate tissue. The 45 reports mostly describe the electrode or metal wire snapping, fraying or wearing out mid-procedure, and the wand failing to deliver energy, sparking or overheating, delaying surgery until a backup device was used. Twelve reports describe injuries, including bleeding requiring a return to the operating room and burns; no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
46
Deaths reported
0
Injuries reported
12
Recalls naming it
0

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00817470000313), received between Feb 21, 2018 and Sep 1, 2026 — classified as 12 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Break” (12 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 2 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 1 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 4 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 3 reportsMar 2026: 0 reportsApr 2026: 5 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break12
  • Degraded7
  • Adverse Event Without Identified Device or Use Problem6
  • Failure to Deliver Energy6
  • Smoking6
  • Activation Failure5
  • Overheating of Device5
  • Fracture4

Patient problems

  • No Clinical Signs, Symptoms or Conditions27
  • Hemorrhage/Blood Loss/Bleeding4
  • No Known Impact Or Consequence To Patient3
  • Burn(s)2
  • Laceration(s)2
  • No Information2
  • No Patient Involvement2
  • Cramp(s) /Muscle Spasm(s)1

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 1, 2026Fracture

    It was reported that during Adenoidectomy, the electrodes tip of one (1) PROCISE EZ VIEW COBLATOR II was broken. The procedure was resumed, without any delay, using an equivalent S+N back-up. No further complications were reported.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50545500 ↗
  • MalfunctionAug 27, 2026Material Separation

    It was reported that, for an Adenotonsillectomy, it was noticed that the electrode of one (1) PROCISE EZ VIEW COBLATOR II snapped off. The procedure was performed, with 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 50488193 ↗
  • MalfunctionApr 21, 2026Overheating of Device; Sparking; Activation Failure

    IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE, THE PROCISE EZ VIEW COBLATOR II FAILED TO PERFORM COBLATION AND SPARKS AND OVERHEATING OCCURRED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24940799 ↗
  • MalfunctionApr 18, 2026Fracture; Detachment of Device or Device Component; Activation Failure

    IT WAS REPORTED THAT DURING AN ADENOIDECTOMY PROCEDURE, THE PROCISE EZ VIEW COBLATOR II WAS UNABLE TO PERFORM COBLATION AND THE ELECTRODE WAS FRACTURED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24919937 ↗
  • MalfunctionApr 18, 2026Degraded; Fracture; Activation Failure

    IT WAS REPORTED THAT DURING AN ADENOIDECTOMY PROCEDURE, THE PROCISE EZ VIEW COBLATOR II'S ELECTRODE WAS FRACTURED AND THE WAND WAS UNABLE TO ABLATE THE TISSUE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24919936 ↗
  • MalfunctionApr 18, 2026Fracture; Activation Failure

    IT WAS REPORTED THAT DURING A ADENOIDECTOMY PROCEDURE, IT WAS NOTICED THAT THE PROCISE EZ VIEW COBLATOR II'S ELECTRODE WAS FRACTURED AND WAS UNABLE TO PERFORM COBLATION. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24919862 ↗
  • InjuryApr 18, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, 3 HOURS AFTER A PARTIAL TONSILLECTOMY HAD BEEN PERFORMED WITH A PROCISE WAND ON (B)(6) 2026, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR HEMOSTASIS UNDER GENERAL ANESTHESIA DUE TO BLOODY SPUTUM. NO FURTHER COMPLICATION WAS REPORTED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 24919860 ↗
  • MalfunctionFeb 16, 2026Degraded

    IT WAS REPORTED THAT, DURING AN ADENOIDECTOMY, A PROCISE EZ VIEW WAND WAS DEFECTIVE, THE ELECTRODES WERE WORN. THE PROCEDURE WAS RESUMED, AFTER A SURGICAL DELAY GREATER THAN 30 MIN, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24344142 ↗
  • MalfunctionFeb 9, 2026Break; Activation Failure

    IT WAS REPORTED THAT, DURING A TONSILLECTOMY PROCEDURE, THE PROCISE WAND'S METAL WIRE BROKE AND IT WAS UNABLE TO CUT THROUGH THE TISSUE. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED, PATIENT STATUS IS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24297599 ↗
  • MalfunctionFeb 2, 2026Break

    IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT THE ELECTRODE OF THE PROCIZE COBLATOR II WAS BROKEN. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT SN 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 24241428 ↗
  • MalfunctionNov 10, 2025Break; Degraded; Break; Degraded

    IT WAS REPORTED THAT, DURING AN ADENOIDECTOMY, THE METAL WIRE OF A PROCISE EZ VIEW WAND BROKE INTO PIECES AND IT WAS UNABLE TO CUT THROUGH THE TISSUE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23509844 ↗
  • MalfunctionNov 10, 2025Break; Degraded; Break; Degraded

    IT WAS REPORTED THAT, DURING AN ADENOIDECTOMY, THE METAL WIRE OF A PROCISE EZ VIEW WAND BROKE INTO PIECES AND IT WAS UNABLE TO CUT THROUGH THE TISSUE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23509827 ↗
  • MalfunctionNov 10, 2025Break; Degraded; Break; Degraded

    IT WAS REPORTED THAT, DURING AN ADENOIDECTOMY, THE METAL WIRE OF A PROCISE EZ VIEW WAND BROKE INTO PIECES AND IT WAS UNABLE TO CUT THROUGH THE TISSUE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS FINE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23509809 ↗
  • MalfunctionNov 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT, DURING AN ENT SURGERY, A SMALL PART OF A PROCISE EZ VIEW WAND WAS LOST. THE PIECE DID NOT FALL INTO THE PATIENT'S MOUTH. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23462415 ↗
  • MalfunctionJul 23, 2025Break; Degraded; Break; Degraded

    IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE METAL WIRE OF THE PROCISE VIEW COBLATOR WAND BROKE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22576044 ↗
  • MalfunctionJul 21, 2025Break; Break

    IT WAS REPORTED THAT DURING A TONSILLECTOMY, THE METAL WIRE OF THE PROCISE VIEW COBLATOR WAND BROKE, THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22562278 ↗
  • InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Failure to Seal; Adverse Event Without Identified Device or Use Problem; Failure to Seal

    IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE PROCIZE EZ WAND CREATED A HOLE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

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

    MAUDE report 21687449 ↗
  • MalfunctionJan 6, 2025Break; Break

    IT WAS REPORTED THAT DURING AN ADENOTONSILLECTOMY, TWO ELECTRODES OF THE PRECISE WAND WERE BROKEN. THE PROCEDURE WAS 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 21080096 ↗
  • MalfunctionDec 20, 2024Failure to Seal; Failure to Seal

    IT WAS REPORTED THAT DURING A TONSILLECTOMY PROCEDURE, THE PROCISE EZ VIEW COBLATOR II TIP WAS MAKING A HOLE IN THE TISSUE OF THE SAME SIZE AS THE TIP PERFORMING HEMOSTASIS AND WAS CAUSING IMMEDIATE BLEEDING AT THE SURGICAL SITE FOR THE PATIENT IN THE OR. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

    MAUDE report 20985338 ↗
  • MalfunctionNov 15, 2024Failure to Deliver Energy; Failure to Deliver Energy

    IT WAS REPORTED THAT DURING A TONSILLECTOMY, THE TIP OF THE WANDWAS NOT PRODUCING PLASMA, ONLY ASPIRATION WHILE BEING CONNECTED TO THE COBLATOR CONTROLLER. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY OF 1 HOUR AND 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20696077 ↗
  • MalfunctionOct 17, 2024Overheating of Device; Smoking; Suction Problem; Output below Specifications; Overheating of Device; Smoking; Suction Problem; Output below Specifications

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE PROCISE EZ VIEW WAND'S ABLATION WAS POOR, WITH SEVERE BLOCKAGE, SMOKING, AND OVERHEATING. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE AND IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Burn(s)

    MAUDE report 20470771 ↗
  • MalfunctionJul 17, 2024Overheating of Device; Smoking; Overheating of Device; Smoking

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE PROCISE COBLATOR II WAS SMOKING AND OVERHEATING AS SOON AS IT WAS ATTACHED, AND WATER STARTED TO BE USED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT SURGICAL TECHNIQUE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19764695 ↗
  • MalfunctionJul 17, 2024Overheating of Device; Smoking; Overheating of Device; Smoking

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE PROCISE COBLATOR II WAS SMOKING AND OVERHEATING AS SOON AS IT WAS ATTACHED, AND WATER STARTED TO BE USED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT SURGICAL TECHNIQUE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19764680 ↗
  • MalfunctionMay 27, 2024Suction Problem; Suction Problem

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TIP OF THE PROCISE EZ WAND DID NOT PROVIDE SUFFICIENT SUCTION, AS IF THE INTERNAL SUCTION CHANNEL WAS PARTIALLY BLOCKED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH A DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19402270 ↗
  • MalfunctionApr 20, 2024Break; Degraded; Overheating of Device; Arcing; Break; Degraded; Overheating of Device; Arcing

    IT WAS REPORTED THAT DURING AN ENT SURGERY, THE PROCISE WAND EMITTED SPARKS, TIP OF THE WAND SEEMS TO BE BROKEN AS PER THE PICTURE PROVIDED. 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 19149834 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.