Coblation EIC4845-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00817470004212), received between Jun 8, 2020 and Jun 24, 2025 — classified as 5 injuries, 10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING AN ENT PROCEDURE, AFTER THE FIRST INSERTION INTO THE PATIENT TURBINATE, THE DOCTOR PULLED OUT THE WAND AND REALIZED THAT THERE WAS SOMETHING ON THE TIP AND FOUND A SMALL PIECE OF PLASTIC. THE DOCTOR CONFIRMED IT WAS NOT FROM THE PATIENT¿S TISSUE BUT LOOKED LIKE A PLASTIC FROM THE WAND. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322271 ↗
• MalfunctionJul 11, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A NASAL OPERATION, THE COBLATOR II HEATED UP EXCESSIVELY, TO LEVELS LIKELY TO CAUSE BURNS TO THE PATIENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DELAY OF LESS 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 19726243 ↗
• MalfunctionMar 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE TIP OF THE REFLEX ULTRA COBLATOR WAND WAS NOT FOUND. THE DOCTOR WAS NOT SURE IF THE TIP WAS INSIDE THE PATIENT OR MELTED. THE PROCEDURE WAS FINISHED WITH THE SAME FAULTY 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 18896037 ↗
• MalfunctionFeb 5, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A SEPTOPLASTY, THE FRONT END OF THE REFLEX ULTRA 45 WAS NOT REACTING WHEN USED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PER THE PRELIMINARY RESULTS OF THE INVESTIGATION, THE FUNCTIONAL EVALUATION REVEALED INTERMITTENT POWER SPARKS WERE OBSERVED IN THE DAMAGED TIP ASSEMBLY ABOVE THE ELECTRODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640847 ↗
• MalfunctionFeb 1, 2024Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT DURING AN ENT SURGERY, THE REFLEX ULTRA 45 COULD NOT ABLATE, THEN WHEN THE DEVICE WAS OUT IT WAS FOUND THAT THE FRONT-END OF REFLEX ULTRA 45 WAS MISSING. NO FOREIGN BODY WAS FOUND BY POSTOPERATIVE X-RAY SCAN. 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 18627550 ↗
• MalfunctionSep 21, 2023Break; Break

  IT WAS REPORTED THAT DURING ENT SURGERY, THE ELECTRODE OF THE REFLEX ULTRA 45 COBLATOR WAS BROKEN IN THE PATIENT'S TISSUE. AFTERWARDS, LOCAL ANESTHESIA WAS PERFORMED FOR SURGERY, THE TIP WAS REMOVED, AND THE PATIENT WAS CURED AND DISCHARGED. 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 17790571 ↗
• MalfunctionSep 18, 2023Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT DURING A PROCEDURE, THE MOST ANTERIOR TIP OF THE REFLEX ULTRA COBLATOR II BROKE IN THE PATIENT'S TISSUE. ALL PIECES WERE REMOVED FROM THE PATIENT'S TISSUE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770002 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "IS THERE A RELATIONSHIP BETWEEN AGE, PERSONAL FACTORS OR SURGICAL FINDINGS, AND OUTCOME AFTER TEMPOROMANDIBULAR JOINT ARTHROSCOPY?", 4 PATIENTS HAD A FAILED TMJ ARTHROSCOPY PROCEDURE USING A REFLEX ULTRA 45 COBLATOR II WAND. THE ISSUE WAS SOLVED WITH AN ADDITIONAL SURGERY, A DISCECTOMY. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15223134 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "IS THERE A RELATIONSHIP BETWEEN AGE, PERSONAL FACTORS OR SURGICAL FINDINGS, AND OUTCOME AFTER TEMPOROMANDIBULAR JOINT ARTHROSCOPY?", 1 PATIENT HAD A FAILED TMJ ARTHROSCOPY PROCEDURE USING A REFLEX ULTRA 45 COBLATOR II WAND. THE ISSUE WAS SOLVED WITH AN ADDITIONAL SURGERY, TO IMPLANT A TMJ PROSTHESIS. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15223133 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "IS THERE A RELATIONSHIP BETWEEN AGE, PERSONAL FACTORS OR SURGICAL FINDINGS, AND OUTCOME AFTER TEMPOROMANDIBULAR JOINT ARTHROSCOPY?", 11 PATIENTS HAD A FAILED TMJ ARTHROSCOPY PROCEDURE USING A REFLEX ULTRA 45 COBLATOR II WAND. THE ISSUE WAS SOLVED WITH AN ADDITIONAL SURGERY, RE-ARTHROSCOPY. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15223132 ↗
• InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW "TRANSSEPTAL SUTURING WITH TURBINATE COBLATION IN NASAL SEPTOTURBINOPLASTY" 1 PATIENT HAD SYNECHIA AFTER A TRANSSEPTAL SUTURE-ASSISTED SEPTOPLASTY AND INFERIOR TURBINATE COBLATION GROUP PROCEDURE USING A REFLEX ULTRA 45 COBLATOR II WAND DEVICE. IT IS UNKNOWN HOW THE EVENTS WERE TREATED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Adhesion(s)

  MAUDE report 15223130 ↗
• MalfunctionNov 13, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT DURING A TURBINATE REDUCTION PROCEDURE, THE REFLEX ULTRA WAND DID NOT COBLATE AS IT SHOULD, IT ACTUALLY BURNED RATHER THAN FORM A PLASMA. THERE WAS NO DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 10835290 ↗
• MalfunctionNov 5, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE FRONT PART OF THE WAND WAS A BIT BROKEN. IT IS UNKNOWN IF A DELAY HAPPENED, WHEN THE ISSUE WAS DISCOVERED AND IF A BACKUP DEVICE WAS AVAILABLE. HOWEVER, NO PATIENT INJURIES WERE REPORTED. 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 10797175 ↗
• MalfunctionSep 15, 2020Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT NO PLASMA WAS GENERATED WHEN USING THE WAND. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. A BACK UP DEVICE WAS USED TO SOLVE THE PROBLEM. 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 10535402 ↗
• InjuryJun 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT WHILE USING REFLEX ULTRA 45 COBLATOR II, THE COATING AT THE END OF THE WAND PEELS OFF AND IT TOOK TIME TO FIND THE MISSING SILICON PIECES THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHIN A DELAY SHORTER THAN 30 MINUTES WITH NO FURTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10131282 ↗