BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEX GENERATOR

    MDR report key: 6012049 · Received October 7, 2016

    Report

    Report Number
    1226420-2016-00144
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 9, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K143175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING AN AORTIC VALVE REPLACEMENT CASE, THE SURGEON INADVERTENTLY ACTIVATED THE PLASMABLADE DEVICE CAUSING A BURN TO THE PATIENT'S CHEST. IT IS UNKNOWN THE SEVERITY OR SIZE OF THE BURN. THE SURGEON REMOVED THE ESCHAR FROM THE BURN. IT IS UNKNOWN IF ANY OTHER INTERVENTIONS WERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662242 AEX GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC 40-405-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention