BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTONSWITCH PENCIL

    MDR report key: 2221481 · Received August 17, 2011

    Report

    Report Number
    1717344-2011-00701
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 11, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON THE PT, THE PENCIL WAS CONNECTED TO THE GENERATOR AND THE BUTTON PUSHED. THE PENCIL WOULD NOT ACTIVATE. ANOTHER PENCIL WAS USED AND IT WORKED W/O ANY PROBLEM. INITIAL EVAL OF THE INCIDENT PENCIL FOUND A HOLE IN THE CORD INSULATION. THE CORD FAILED HIPOT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUTTONSWITCH PENCIL ES ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 201919

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK