BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REUSABLE PENCIL W/15FT CORD 50U

    MDR report key: 4120831 · Received July 28, 2014

    Report

    Report Number
    1717344-2014-00646
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 9, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE INCIDENT PENCIL CONFIRMED THE ACTIVATION BUTTON STICKS IN THE ON POSITION. THE ROOT CAUSE WAS IDENTIFIED AS A MANUFACTURING ERROR. THE SWITCH DOME WAS INVERTED AND MACHINE MALFUNCTION CAUSED THE STAMPING TO BE MISALIGNED TO THE PLASTIC SWITCHBASE. ADDITIONALLY, IF THE PENCIL BECOMES DEFORMED DURING REPROCESSING, THIS MARGINAL MISALIGNMENT COULD DEFORM THE STAMPING PLACEMENT, POSSIBLY RESULTING IN A STUCK BUTTON. CORRECTIVE ACTION HAS BEEN IMPLEMENTED TO PREVENT IMPROPER ALIGNMENT. THE INCIDENT DEVICE WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFTING PROCEDURE THE PENCIL SELF ACTIVATED. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS FINISHED WITH ANOTHER PENCIL SO THE PROBLEM HAD NO IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440022 REUSABLE PENCIL W/15FT CORD 50U ES ACCESSORY, REUSABLE GEI COVIDIEN LP 242167X

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR