Coblation EICA4845-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00817470003734), received between Mar 27, 2019 and Apr 30, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN (B)(6) 2025, AN 11-YEAR-OLD PATIENT UNDERWENT A ROUTINE TONSILLECTOMY IN WHICH A REFLEX ULTRA 45 COBLATOR II WAND WAS INVOLVED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED POST-TONSILLECTOMY HEMORRHAGING, WHICH REQUIRED INTERVENTIONAL RADIOLOGY (IR) COIL EMBOLIZATION. THREE DAYS AFTER THE SURGERY THE PATIENT BEGAN VOMITING BLOOD AND BLEEDING FROM THE CAROTID ARTERY, RESULTING IN SURGERY, IN WHICH, THE PATIENT WENT INTO CARDIAC ARREST FOR NEARLY 10 MINUTES. THE DOCTORS WERE ABLE TO SAVE HIM, BUT THEY HAD TO BE PLACED IN MEDICAL INDUCE COMA ON (B)(6) 2025, FOR 10 DAYS. CURRENTLY, THE PATIENT IS RELEARNING HOW TO EAT, TALK, AND WALK. THE DOCTORS ARE EXPECTING TO RECOVERY; HOWEVER, THE PATIENT HAS UPCOMING SURGERIES DUE TO A BLOOD CLOT IN HIS ARTERY. THE CAUSE AND FURTHER DETAILS ARE UNKNOWN AT THIS TIME.

  Patient problems: Coma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21932543 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TURBINATE REDUCTION SURGERY WITH THE REFLEX ULTRA COBLATOR II, IT HAD RESULTED IN POSTOPERATIVE SECONDARY ATROPHIC RHINITIS IN BOTH NASAL VALVES, DISRUPTED BASIC NASAL BREATHING FUNCTION WITH A SIGNIFICANT ADVERSE DECREASE IN NASAL AIRFLOW RESISTANCE (AIRWAY WAS OVER EXPANDED, NASAL BREATHING BECAME EQUIVALENT OF MOUTH BREATHING), MUCOSAL DAMAGE POST THERMAL DESTRUCTION THROUGH COBLATION. AND NEW CHRONIC CONDITION OF SEVERE NASAL DRYNESS (ONLY 0-5% MUCUS PRESENT), ULCERATION IN THE LEFT NASAL VALVE WHERE THE TURBINATE STRUCTURES WERE IRREVERSIBLY DAMAGE/REDUCED BY 50-55% ON THE LEFT SIDE (VS 21-25% ON THE RIGHT SIDE), NASAL VALVES COLLAPSE, ULCERATION IN THE NASAL VALVES, WITH INCREASINGLY EXCESSIVE DRYNESS, HIGH VELOCITY AIR VORTEX, SEVERE INTERNAL NASAL VALVE COLLAPSE ON BOTH SIDES (>2.0MM ON EACH SIDE DURING NORMAL INHALATION EFFORT), CHRONIC OBSTRUCTION IN THE LEFT NASAL VALVE CAUSED BY SEVERE MUCOSAL DRYNESS, POOR AIR FILTERING WITH COLD AIR HITTING THE PATIENT'S NASOPHARYNX, ANOSMIA/LOSS OF SMELL - COMPLETE ON THE LEFT SIDE, PARTIAL ON THE RIGHT SIDE, OBSTRUCTIVE SLEEP APNEA (THE PATIENT STARTED USING THE CPAP MACHINE), EXTREME SYMPTOMS OF ANXIETY

  Patient problems: Adult Respiratory Distress Syndrome; Anxiety; Decreased Respiratory Rate; Depression; Distress; Fatigue; Hemorrhage/Blood Loss/Bleeding; Nasal Obstruction; Pain; Sleep Dysfunction; Upper Respiratory Tract Injury

  MAUDE report 16112739 ↗
• InjurySep 16, 2022Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A TURBINATE REDUCTION PROCEDURE, FOUR (4) REFLEX ULTRA 45 WANDS WERE READING 0,2 UPON INITIAL PLUG IN. THEY WERE TESTED WITH THREE DIFFERENT GENERATORS, BUT THE ISSUE PERSISTED. PROCEDURE WAS CANCELED AFTER A DELAY GREATER THAN 30 MINUTES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15440018 ↗
• MalfunctionSep 16, 2022Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THE REFLEX ULTRA 45 READ 0, 2 WHEN IT WAS PLUGGED INTO THE GENERATOR. PROCEDURE RESUMED AFTER A 1 HOUR DELAY, HOWEVER IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439944 ↗
• MalfunctionJul 4, 2022Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, TWO REFLEX ULTRA WERE SHOWING UP AS 0 ON COBLATE AND 2 ON COAG ON THE FIRST PLUG IN. IT IS UNKNOWN IF THE DEVICE WAS INSIDE OR OUTSIDE THE PATIENT WHEN THE ISSUE OCCURRED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. A 1 HOUR SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911681 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FOLLOW UP WITH THE PATIENT, THE SURGEON NOTICED LIP BURNS FROM THE SHAFT OF THE WAND.

  Patient problems: Burn(s)

  MAUDE report 8455552 ↗