BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN ENT REFLEX ULTRA PLASMA WAND AND TURBINATOR WAND

    MDR report key: 13995670 · Received April 4, 2022

    Report

    Report Number
    3006524618-2022-00142
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    July 1, 2008
    Report Date
    May 20, 2022
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K202006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE: XU HAI, CAI HUACHENG, LI SHULAN, LI ZHIQIANG, & FRESH KUNLUN. (2008). 43 CASES OF REFRACTORY EPISTAXIS WERE TREATED WITH A LOW-TEMPERATURE PLASMA ABLATION SYSTEM UNDER NASAL ENDOSCOPY. ARMED POLICE MEDICINE, 19(7), 657-658.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: CASE(B)(4). THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD 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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A DEVICE LABELING/IFU REVIEW COULD NOT BE CONDUCTED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. PER CASE DETAILS NO FURTHER INFORMATION IS AVAILABLE. WITHOUT SUPPORTING CLINICAL/MEDICAL DOCUMENTS, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-EVALUATED. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. 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 "TREATMENT OF REFRACTORY EPISTAXIS WITH CRYOGENIC PLASMA ABLATION SYSTEM UNDER NASAL ENDOSCOPE IN 43 CASES", TWO PATIENTS HAD A UNSUCCESSFUL HEMOSTASIS AFTER A PROCEDURE FOR THE TREATMENT OF REFRACTORY EPISTAXIS USING A REFLEX ULTRA 45 WAND AND THE COBLATOR SURGERY SYSTEM. THE EVENTS WERE RESOLVED BY PERFORMING A SECOND HEMOSTASIS IN A REVISION SURGERY. PATIENTS WERE DISCHARGE WITHIN ONE WEEK AFTER WITH NO BLEEDING. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620606 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 Hospitalization