BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE HANDSW PENCIL

    MDR report key: 1900067 · Received November 9, 2010

    Report

    Report Number
    1717344-2010-00799
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    COVIDIEN LP (FORMERLY VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    WHEN USING SURGICAL PENCIL, IT IS STILL HOT AND BURNS THE GOWN WHEN THE BUTTONS ARE NOT TOUCHED. THE PENCIL IS STILL "HOT" EVEN WHEN IT IS NOT BEING ACTIVATED AND ACCIDENTALLY BURNT A PT'S GOWN AND A DOCTOR'S GOWN. NO INJURY ASSOCIATED WITH THE EVENT. A HOLSTER IS SUPPLIED WITH THE PRODUCT TO HOLD THE PENCIL WHEN NOT IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE HANDSW PENCIL ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (FORMERLY VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK