BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE CT PEN ROCKER HLSTR GAYLD

    MDR report key: 2113030 · Received May 25, 2011

    Report

    Report Number
    1717344-2011-00408
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 3, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 DURING A BREAST AUGMENTATION PROCEDURE, WHILE USING A PENCIL IN THE BREAST POCKET WHEN THEY SAW AN ARC. THE PATIENT RECEIVED A BURN ON THE INCISION LINE. THE BURNT TISSUE WAS EXCISED AND THE AREA INCLUDED IN THE CLOSING. A STAFF MEMBER CHECKED TO SEE IF THE ELECTRODE WAS FULLY INSERTED AND REPORTED IT WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDGE CT PEN ROCKER HLSTR GAYLD ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 197914

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR ES BLADE ELECTRODE, E1455, LOT # 196782