BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE INSUL. COATED BLADE

    MDR report key: 3210002 · Received June 26, 2013

    Report

    Report Number
    1717344-2013-00456
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE NUMBER: (B)(4). DATE OF INITIAL REPORT: (B)(4) 2013. VISUAL INSPECTION OF THE RETURNED SAMPLE FOUND THE CLEAR INSULATOR LOOSE IN THE RETURNED CONTAINER ALONG WITH THE ELECTRODE. THE ELECTRODE BLADE AND INSULATION WERE SCRATCHED AND TORN. THERE WAS EXCESSIVE ESCHAR ON THE ELECTRODE BLADE. ONLY THE TIP OF THE ELECTRODE SHOULD MAKE CONTACT WITH TARGET TISSUE. THE INSTRUCTIONS FOR USE STATE THAT CLEANING THE ELECTRODE WITH A SCRATCH PAD OR OTHER ABRASIVE OBJECT, OR SCRAPING WITH A SHARP OBJECT, MAY DAMAGE THE ELECTRODE. IF THE ELECTRODE BECOMES DAMAGED, IT SHOULD BE DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULATION FELL OFF WHILE THEY WERE ACTIVATING THE DEVICE. THE PIECE FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED WITHOUT ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291356 EDGE INSUL. COATED BLADE ES ACCESSORY GEI COVIDIEN LP 250245X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK