BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP HNDSW PENCIL W/HOLSTER

    MDR report key: 2033063 · Received February 28, 2011

    Report

    Report Number
    1717344-2011-00156
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CUT WOULD NOT WORK ON PENCIL AND COAG WAS ACTIVATING LIKE IT WAS STUCK AND WOULD NOT TURN OFF, EVEN THOUGH IT WASN'T PUSHED DOWN. IT WAS REMOVED FROM THE FIELD. ANOTHER PENCIL WAS OPENED AND THE CASE COMPLETED. THERE WAS NO PATIENT HARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK