BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE CT PEN ROCKER HLSTR GAYLD

    MDR report key: 1883905 · Received October 22, 2010

    Report

    Report Number
    1717344-2010-00717
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 29, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THERE WAS A 1ST DEGREE BURN ON LEFT FOREARM, 1- 2 INCHES LONG WHICH WAS TREATED WITH BACITRACIN. AFTER THE INITIAL INCISION WAS MADE, THE SURGEON PICKED UP THE PENCIL AND TOLD THE STAFF IT WAS NOT WORKING PROPERLY. THE STAFF NOTICED THAT WHEN THE SURGEON PUSHED COAG, THE CUT LIGHT ON THE GENERATOR LIT UP. A NEW PENCIL WAS BEING PLACED ON THE FILED WHEN THE SURGEON SET DOWN THE FIRST PENCIL ON THE PT'S ARM. NO ONE IN THE ROOM WAS AWARE THAT THE PENCIL WAS HOT AND THIS RESULTED IN THE FIRST DEGREE BURN. THE SECOND PENCIL WAS USED TO COMPLETE THE CASE WITHOUT ISSUE. AT THE END OF THE CASE, THE FIRST PENCIL, WHICH HAD MALFUNCTIONED, WAS TESTED. THE CUT FUNCTION LIT UP WITHOUT ANYONE PRESSING THE ROCKER SWITCH WHEN THE PENCIL WAS PLUGGED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDGE CT PEN ROCKER HLSTR GAYLD ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 186386

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR