BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDSWITCH PENCIL W/HOLSTER

    MDR report key: 1432773 · Received May 5, 2009

    Report

    Report Number
    1717344-2009-00176
    Event Type
    Malfunction
    Date Received
    May 5, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 7, 2009
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 05/05/2009. THE INCIDENT DEVICE WAS CHECKED FOR CONTINUITY WITH ACCEPTABLE RESULTS. WHEN PLUGGED IN TO A 40K OHM TEST BOX, THE DEVICE PASSED THE SELF KEY TEST. THE DEVICE WAS DISASSEMBLED TO INSPECT THE SWITCHBASE. SIGNS OF CORROSION AND RUST AT THE ELECTRODE INSERTION POINT WERE FOUND AS IF THE DEVICE WAS EXPOSED TO MOISTURE OVER AN EXTENDED PERIOD OF TIME OR A STERILIZATION PROCESS WHICH COULD CAUSE SELF ACTIVATION TO OCCUR. WE WERE UNABLE TO DUPLICATE THE CUSTOMER'S REPORT OF SELF ACTIVATION. THE PENCIL SWITCH IS SEALED AND FLUID RESISTANT. IF CONDUCTIVE FLUID FILLS THE INSIDE OF THE PENCIL BODY, THAT FLUID CAN CARRY CURRENT FROM THE ELECTRODE CONTACT THROUGH THE INTERIOR OF THE PENCIL. THIS PENCIL IS SINGLE USE ONLY AND IS NOT DESIGNED TO WITHSTAND RESTERILIZATION. THE IFU FOR THIS DEVICE STATES TO DISCARD THE PENCIL, ELECTRODE AND HOLSTER AFTER USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON THE PT, THE ELECTROSURGICAL PENCIL WAS PLUGGED INTO THE GENERATOR AND THE PENCIL IMMEDIATELY ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDSWITCH PENCIL W/HOLSTER ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CONMED GENERATOR - MODEL AND S/N UNK