BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENT REFLEX ULTRA PLASMA WAND AND TURBINATOR WAND

    MDR report key: 15859952 · Received November 24, 2022

    Report

    Report Number
    3006524618-2022-00488
    Event Type
    Injury
    Date Received
    November 24, 2022
    Date of Event
    January 1, 2017
    Report Date
    January 18, 2023
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K202006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). GU, A., & BAUMAN, N. M. (2017). BIPOLAR RADIOFREQUENCY ABLATION (COBLATION) OF EXTERNAL AUDITORY CANAL LYMPHATIC MALFORMATION AND OTHER SOFT STENOSES. ANNALS OF OTOLOGY, RHINOLOGY & LARYNGOLOGY, 126(12), 835-838. DOI: 10.1177/0003489417739011.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE (B)(4). H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY REVIEW, COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THE INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A CLINICAL REVIEW STATES THIS CASE REPORTED FROM A LITERATURE REVIEW ARTICLE DOCUMENTS THAT A 10 YEAR OLD FEMALE WITH A MICROCYSTIC LYMPHATIC MALFORMATION BEING TREATED WITH TWO EXTERNAL AUDITORY CANAL (EAC) COBLATION PROCEDURES USING A REFLEX ULTRA PTR WAND EXPERIENCED A PINPOINT TYMPANIC MEMBRANE PERFORATION AFTER THE FIRST PROCEDURE. IN ADDITION, THE PHYSICIAN REFERENCED IN THE ABSTRACT PROVIDED AN ANALYSIS OF ALL OF THE ATTACHED IMAGES. THEREFORE, NO FURTHER INTERPRETATION OF THE ATTACHED IMAGES IS REQUIRED. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION. CORRECTION IN H6 (HEALTH EFFECT - IMPACT CODE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "BIPOLAR RADIOFREQUENCY ABLATION (COBLATION) OF EXTERNAL AUDITORY CANAL LYMPHATIC MALFORMATION AND OTHER SOFT STENOSES", 1 PATIENT EXPERIENCED A PINPOINT TYMPANIC MEMBRANE PERFORATION AFTER A EAC SURGERY PROCEDURE USING A REFLEX ULTRA PTR WAND DEVICE. THE PERFORATION HEALED SPONTANEOUSLY 2 WEEKS LATER. PATIENT HAD RESOLUTION OF THEIR EAC SYMPTOM AFTER 2 PROCEDURES SPACED 8 WEEKS APART. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897626 UNKNOWN ENT REFLEX ULTRA PLASMA WAND AND TURBINATOR WAND ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Required Intervention