BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SPINE WAND AND CONTROLLER

    MDR report key: 13995837 · Received April 4, 2022

    Report

    Report Number
    3006524618-2022-00177
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    February 23, 2021
    Report Date
    July 14, 2022
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). PANDOLFI, M., GALLI, F., BORELLI, A., GURGITANO, M., LIGUORI, A., & CARRAFIELLO, G. (2021). PERCUTANEOUS CERVICAL COBLATION AS THERAPEUTIC TECHNIQUE IN THE TREATMENT OF ALGO-DYSFUNCTIONAL PAIN OF DISCAL HERNIATION. LA RADIOLOGIA MEDICA, 126(6), 860-868.

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT - IMPACT CODE UPDATED. 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. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO 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. OUR CLINICAL INVESTIGATION CONCLUDED: WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. 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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS MANUFACTURING RECORD, COMPLAINT HISTORY, DEVICE LABELING, AND RISK MANAGEMENT REVIEWS COULD NOT BE PERFORMED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. 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 THE LITERATURE REVIEW "PERCUTANEOUS CERVICAL COBLATION AS THERAPEUTIC TECHNIQUE IN THE TREATMENT OF ALGO-DYSFUNCTIONAL PAIN OF DISCAL HERNIATION"; 2 PATIENTS WERE REQUIRED TO RETURN TO THE OPERATIVE ROOM FOR AN UNKNOWN REASON AFTER A PERCUTANEOUS CERVICAL COBLATION USING A SPINE WAND. THE PATIENTS' OUTCOMES ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493222 UNKN SPINE WAND AND CONTROLLER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention