BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX ULTRA 45 COBLATOR II

    MDR report key: 15976403 · Received December 13, 2022

    Report

    Report Number
    MW5113752
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    November 17, 2021
    Report Date
    December 11, 2022
    Manufacturer
    SMITH & NEPHEW, INC., ENDOSCOPY DIVISION
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE USE OF REFLEX ULTRA 45 COBLATOR II (REF NUMBER EICA4845-01) BY SMITH & NEPHEW, INC. HAS RESULTED IN POSTOPERATIVE SECONDARY ATROPHIC RHINITIS ("EMPTY NOSE SYNDROME") IN BOTH NASAL VALVES, DISRUPTED BASIC NASAL BREATHING FUNCTION WITH A SIGNIFICANT ADVERSE DECREASE IN NASAL AIRFLOW RESISTANCE (AIRWAY WAS OVEREXPANDED, NASAL BREATHING BECAME EQUIVALENT OF MOUTH BREATHING), MUCOSAL DAMAGE POST THERMAL DESTRUCTION THROUGH COBLATION - FOR DETAIL, PLEASE SEE "HISTOPATHOLOGICAL CHANGES AFTER COBLATION INFERIOR TURBINATE REDUCTION" (PUBLISHED IN ARCH OTOLARYNGOLOGY HEAD NECK SURGERY. 2008; 134(8): 819-823), BERGER G., OPHIR D, PITARO K. AND LANDSBERG R. (REFLEX ULTRA 45 WAND LEADS TO SIGNIFICANT FIBROSIS, GLANDULAR AND SINUSOID DEPLETION, PARTIAL EPITHELIAL SHEDDING OF THE CILIA) - 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 DAMAGED/REDUCED BY 50-55% ON THE LEFT SIDE (VS. 21-25% ON THE RIGHT SIDE), NASAL VALVES COLLAPSE. A SURGICAL ERROR AND THE RESULT OF UNNECESSARY TURBINATE REDUCTION USING THE REFLEX ULTRA 45 COBLATOR II (REF NUMBER EICA4845-01) BY SMITH & NEPHEW, INC. THE REFLEX ULTRA 45 COBLATOR II DEVICE WAS USED BY UNSUPERVISED FELLOW DR (B)(6) WHO HADN'T HAD ANY SIGNIFICANT EXPERIENCE IN INDEPENDENTLY PERFORMING COMPLEX FUNCTIONAL PROCEDURES LIKE TURBINATE REDUCTION. THE USE OF REFLEX ULTRA PTR WAND DEVICE REQUIRES "AN APPROPRIATE LEVEL OF SURGICAL SKILL AND EXPERIENCE", "COMPLETION OF A SKILLS LABORATORY, TRAINING BY THE MANUFACTURER OR ONE OF ITS APPOINTED REPRESENTATIVES AND OBSERVATION OF SIMILAR SURGICAL PROCEDURES", "THE SURGEON SHOULD ADVISE THE PATIENT OF THE KNOWN RISKS AND COMPLICATIONS ASSOCIATED WITH THE SURGICAL PROCEDURE AND USE OF THIS PRODUCT". THE PATIENT WASN'T INSTRUCTED ON ANY OF THE RISKS OF THE PROCEDURE AND WENT INTO THE OPERATING ROOM, THINKING I WOULD HAVE A LIMITED COSMETIC PROCEDURE, NOT FULL-SCALE FUNCTIONAL CHANGES TO THE PATIENT'S NASAL BREATHING FUNCTION. USING THE COBLATOR II CONTROLLER WITH REFLEX ULTRA 45 COBLATOR II DEVICE. NONE BEFORE TURBINATE REDUCTION SURGERY ON (B)(6) 2021, RESPIRATORY DISTRESS AFTER SURGERY ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407315 REFLEX ULTRA 45 COBLATOR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SMITH & NEPHEW, INC., ENDOSCOPY DIVISION EICA4845-01 2023368
    1407316 COBLATOR II CONTROLLER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SMITH & NEPHEW, INC. / ARTHROCARE CORPORATION EC8000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Other| R| S B-12| CPAP