BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND-TROL

    MDR report key: 1003914 · Received January 28, 2008

    Report

    Report Number
    1003914
    Event Type
    Malfunction
    Date Received
    January 28, 2008
    Date of Event
    October 16, 2007
    Report Date
    November 30, 2007
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    THE ELECTROSURGICAL PENCIL CONTINUED TO RUN AFTER BUTTON WAS RELEASED. THE PENCIL WAS REPLACED. THERE WAS NO HARM TO PATIENT. ADDITIONAL DEVICE INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAND-TROL ELECTRODE, ESU, PENCIL GEI CONMED ELECTROSURGERY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR