BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN ENT REFLEX ULTRA PLASMA WAND AND TURBINATOR WAND

    MDR report key: 15463242 · Received September 22, 2022

    Report

    Report Number
    3006524618-2022-00418
    Event Type
    Injury
    Date Received
    September 22, 2022
    Date of Event
    January 1, 2012
    Report Date
    January 12, 2023
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K202006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE: LI YUNQIU, XIAO XUPING, TAN ZHIQIANG, & MIAO GANGYONG. (2012). LONG-TERM EFFICACY OBSERVATION OF LOW TEMPERATURE PLASMA ABLATION COMBINED WITH INFERIOR TURBINATE FRACTURE LATERALIZATION IN THE TREATMENT OF INFERIOR TURBINATE HYPERTROPHY. JOURNAL OF CLINICAL OTOLARYNGOLOGY HEAD AND NECK SURGERY, 26(23), 1095-1097.

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY REVIEW, RISK MANAGEMENT REVIEW, AND AN INSTRUCTIONS FOR USE/DEVICE LABELING 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. BASED ON A REVIEW OF THIS INVESTIGATION, AS OF THE DATE OF THIS MEDICAL INVESTIGATION, THE REQUESTED CLINICAL DOCUMENTATION HAS NOT BEEN PROVIDED. THEREFORE, THERE WERE NO CLINICAL FACTORS FOUND WHICH WOULD HAVE CONTRIBUTED TO THE EVENT, AS IT HAS BEEN COMMUNICATED, NO ADDITIONAL INFORMATION IS AVAILABLE. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. THE PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE AGED ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION/DOCUMENTATION BECOME AVAILABLE, THE CLINICAL/MEDICAL TASK MAY BE RE-OPENED FOR FURTHER EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. 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.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "LOW-TEMPERATURE PLASMA ABLATION COMBINED WITH THE TREATMENT OF INFERIOR TURBINATE FRACTURE ECTOPIC. LONG-TERM EFFICACY OBSERVATION OF INFERIOR TURBINATE HYPERTROPHY. THE LONGTERM EFFECT OF COBLATION COMBINED LATERAL FRACTURE IN THE TREATMENT OF INFERIOR TURBINATE HYPERTROPHY ", 2 PATIENTS WITH ALLERGIC RHINITIS RELAPSED 6 MONTHS LATER AFTER A LOW-TEMPERATURE PLASMA ABLATION WHERE A REFLEX 45 COBLATION WAND AND SYSTEM WERE USED. THE 2 PATIENT HAD TO BE REOPERATED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694404 UNKN ENT REFLEX ULTRA PLASMA WAND AND TURBINATOR WAND ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other