BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCKERSWITCH PENCIL

    MDR report key: 2253198 · Received August 3, 2011

    Report

    Report Number
    1717344-2011-00642
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED 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 SOON AFTER THE PENCIL WAS CONNECTED TO THE GENERATOR, THE CUT FUNCTION ACTIVATED AUTOMATICALLY. THE PENCIL WAS REPLACED WITH ANOTHER. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCKERSWITCH PENCIL ESU ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 202833X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK