MAUDE Adverse Event Report: ARTHROCARE CORPORATION COBLATOR II CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number EC8000-01

Patient Problems Apnea (1720); Dyspnea (1816); Fatigue (1849); Nerve Damage (1979); Burning Sensation (2146); Anxiety (2328); Depression (2361); Nasal Obstruction (2466); Decreased Sensitivity (2683); Fibrosis (3167); Unspecified Respiratory Problem (4464); Cramp(s) /Muscle Spasm(s) (4521); Unspecified Tissue Injury (4559)

Event Date 06/20/2018

Event Type  Injury  

Event Description

The use of coblator system controller ii (ec8000-01), also known as "coblator ii controller", manufactured by arthrocare corp.(owned by smith & nephew, inc.) and turbinator wand (eica6895-01), powered by coblator ii controller, manufactured by smith & nephew, inc., has resulted in a delayed postoperative secondary atrophic rhinitis and an iatrogenic breathing disorder, formally diagnosed as "empty nose syndrome" (j34.89 (icd-10-cm)]) in both nasal valves, having a direct connection to coblation that resulted in severe damage of inferior turbinate.The inferior turbinate volume has been reduced by (b)(4) bilaterally.The following empty nose syndrome symptoms are present post turbinate reduction procedure with turbinator wand (eica6895-01) with coblator ii controller (ec8000-01): nasal burning, dyspnea, central sleep apnea (from missing trpm8 receptors), jolts before sleep, restless legs at night, paradoxical nasal obstruction, depression, anxiety, fatigue, occasional ear fullness, internal valves collapse, disrupted nasal cycle, 30-40% decrease in sense of smell, decrease in nasal airflow resistance and nasal airflow pattern, nerve damage, severe intranasal dryness (from histopathological and surface damage to mucosa), leading to frequent clogging of posterior nasal passages, and lack of natural intranasal air warming, humidification and filtering, as inferior turbinates are now severely and irreversibly damaged.This inferior turbinate damage has resulted in nasal breathing becoming unnatural, equal to mouth breathing in terms of airflow resistance (lack of).Inferior turbinates' trpm cold receptors, nerves, blood vessels and mucosa were irreversibly damaged.The use of the turbinator wand has also led to significant fibrosis, glandular and sinusoid depletion, partial epithelial shedding of the cilia, and a chronic condition of severe intranasal dryness from ulceration in internal nasal valves (both sides) in the sites where turbinate reduction through coblation was performed.Those histopathological elements of the patient's inferior turbinates were irreversibly damaged.Several leading experts on "empty nose syndrome" that the patient has consulted with, were aghast as this clinically unproven, investigational and experimental procedure of turbinate reduction through coblation is still being conducted, without any consideration for patient safety and wellbeing.The inferior turbinates serve an important physiological function in patients' overall health and quality of life.This patient was only given the most minimal mentioning of the procedure, accompanied by a wrong diagnosis of "turbinate hypertrophy", as the patient reported no nasal breathing obstruction preoperatively.The patient was not instructed on the risks of the procedure of turbinate reduction through coblation, the technique and instruments that the doctor was going to use on the patient, were not disclosed prior to the procedure.The patient went in for a limited cosmetic procedure but instead got a turbinectomy and a full nasal reconstruction procedure, adversely impacting the basic nasal breathing function and misplacing vital parts of nasal anatomy, with a major contributor being the coblator ii system that included turbinator wand (eica6895-01) and coblator ii controller (ec8000-01).Reference report mw5147955.

• Brand Name: COBLATOR II CONTROLLER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION
• MDR Report Key: 18100522
• MDR Text Key: 328110855
• Report Number: MW5147956
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC8000-01
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: B12 COMPLEX.; BORON .; VIT. K2, C.
• Patient Outcome(s): Disability; Hospitalization; Other; Required Intervention
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White