BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISP HNDSW PENCIL W/HOLSTER

    MDR report key: 996270 · Received January 30, 2008

    Report

    Report Number
    1717344-2008-00037
    Event Type
    Injury
    Date Received
    January 30, 2008
    Date of Event
    July 11, 2007
    Report Date
    January 3, 2008
    Manufacturer
    COVIDIEN LP (COVIDIEN)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PENCIL WAS DISPOSED OF BY THE SITE, BUT DID CONFIRM THIS WAS AN ACCIDENTAL ACTIVATION CAUSED BY THE DR LEANING HIS ELBOW ON THE DEVICE. THE CUSTOMER CONFIRMED THIS WAS A COVIDIEN LP PENCIL, BUT DID NOT KNOW THE CATALOG NUMBER. HOWEVER, FROM THE DESCRIPTION IN THE MEDWATCH, IT WOULD BE A DISPOSABLE PENCIL WITH A HOLSTER. THE IFU FOR THIS TYPE OF PROD CONTAINS THE WARNING: "WHEN NOT IN USE, PLACE ACTIVE ACCESSORIES IN A HOLSTER OR IN A CLEAN, DRY, NON-CONDUCTIVE, AND HIGHLY VISIBLE AREA NOT IN CONTACT WITH THE PT. INADVERTENT CONTACT WITH THE PT MAY RESULT IN BURNS."

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A PROCEDURE A COVIDIEN LP (FORMERLY VALLEYLAB) ELECTROSURGICAL PENCIL WAS PLACED ON PT'S CHEST, NOT IN HOLSTER, BY THE SURGEON. THE SURGEON ACCIDENTALLY LEANED AGAINST THE PENCIL AND ACTIVATED IT. THE PT SUSTAINED A 2MM BY 1MM DEEP BURN ON THE LEFT BREAST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention