BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESCULAP, MONOPOLAR CORD

    MDR report key: 7746471 · Received August 3, 2018

    Report

    Report Number
    7746471
    Event Type
    Malfunction
    Date Received
    August 3, 2018
    Date of Event
    June 27, 2018
    Report Date
    July 30, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL CASE, THE MONOPOLAR CORD SEVERED CAUSING SPARK AND FLAME TO RUN THE COURSE OF THE CORD TOWARD THE BOVIE MACHINE. THE RN IMMEDIATELY EXTINGUISHED THE SPARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588482 AESCULAP, MONOPOLAR CORD ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI AESCULAP IMPLANT SYSTEMS, LLC US354 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10585 DA