BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP HDSW PENCIL W/PSHBTTN-NSB

    MDR report key: 2851434 · Received October 31, 2012

    Report

    Report Number
    1717344-2012-01130
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 25, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PRIOR TO USE, IT WAS NOTED THAT THE PENCIL CABLE WAS DAMAGED. THERE WAS NO PT INVOLVEMENT. INITIAL EVALUATION OF THE INCIDENT DEVICE CONFIRMED THE CORD WAS DAMAGED AND FAILED HIPOT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP HDSW PENCIL W/PSHBTTN-NSB ES ACCESSORY - NON STERILE GEI COVIDIEN LP 229724X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK