BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDED COATED BLADE

    MDR report key: 3896997 · Received May 13, 2014

    Report

    Report Number
    1717344-2014-00415
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Report Date
    May 6, 2014
    Manufacturer
    COVIDIEN LP,
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION OF THE INCIDENT DEVICE FOUND THE ELECTRODE TIP WAS CHARRED. THE CHARRING IS A RESULT OF THE REPORTED SPARKING AND FLAME. THE ROOT CAUSE WAS DETERMINED TO BE FROM THE ELECTRODE COMING INTO CONTACT WITH A METAL OBJECT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROBOTIC COLECTOMY, AN ELECTRODE SPARKED DURING USE. THE SURGEON WAS BUZZING THE HEMOSTAT AND THE ELECTRODE HAD A BIT OF FLAME ON THE END. IT HAPPENED OUTSIDE THE PATIENT AND THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287575 EXTENDED COATED BLADE ES ACCESSORY GEI COVIDIEN LP, 3140067X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK