BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASG-300R

    MDR report key: 7740281 · Received August 1, 2018

    Report

    Report Number
    3007593903-2018-00038
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    July 12, 2018
    Report Date
    July 25, 2018
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K022856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    REPORTED COMPLAINT ALLEGED THAT THE ELECTROSURGICAL UNIT RAMPS UP/DOWN IN COAGULATION POWER SETTING WHEN TOUCHING THE DISPLAY. NO PATIENT INJURY RESULTED FROM THE REPORTED COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582966 ASG-300R ASG-300R GEI BOVIE MEDICAL CORPORATION ASG-300R

    Patients

    Seq Age Sex Outcome Treatment
    1