BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE PENCILW/15FT CORD 50U

    MDR report key: 3210024 · Received June 26, 2013

    Report

    Report Number
    1717344-2013-00453
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 4, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE NUMBER: (B)(4). DATE OF INITIAL REPORT: (B)(4) 2013. THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PENCIL ACTIVATED IN THE COAG MODE WITHOUT THE BUTTON BEING PUSHED. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291357 REUSABLE PENCILW/15FT CORD 50U REUSABLE ES ACCESSORY GEI COVIDIEN LP 222775X

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR