BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTONSWITCH PENCIL

    MDR report key: 4140732 · Received October 3, 2014

    Report

    Report Number
    1717344-2014-00872
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE INCIDENT DEVICE FOUND IT TO SELF-ACTIVATE IN THE CUT MODE. INSPECTION FOUND THE CUT DOME HAD COLLAPSED, CAUSING THE SELF-ACTIVATION. THE CAUSE OF THE COLLAPSED DOME COULD NOT BE DETERMINED. NO TREND HAS BEEN IDENTIFIED FOR THIS FAILURE MODE.

    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 IN A GASTROENTEROSTOMY BYPASS PROCEDURE, THE DEVICE DID NOT ACTIVATE WHEN THE BUTTON WAS PRESSED. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.COVIDIEN'S INITIAL EVALUATION FOUND THE DEVICE TO SELF-ACTIVATEIN THE CUT MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620941 BUTTONSWITCH PENCIL ES ACCESSORY GEI COVIDIEN LP E2450H

    Patients

    Seq Age Sex Outcome Treatment
    1