BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 2041520 · Received March 10, 2011

    Report

    Report Number
    1717344-2011-00155
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 24, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A THYROIDECTOMY, THE PT REC'D A BURN FROM THE SHAFT OF AN OLSEN MEDICAL JEWELER'S FORCEPS. THE FORCEPS WERE PLUGGED INTO THE GENERATOR USING AN OLSEN MEDICAL BIPOLAR CORD WITH AN (B)(4) ADAPTOR. THE PT BURN WAS DESCRIBED AS BEING 1CM-2CM IN LENGTH. THE DEGREE OF BURN AND TREATMENT OF THE BURN WERE NOT SUPPLIED FROM THE SITE. THE SURGEON REPORTED THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OSLEN MEDICAL BIPOLAR CORD - LOT # UNKNOWN| OLSEN MEDICAL JEWELERS FORCEPS - LOT # UNKNOWN| (B)(4) ADAPTOR - LOT # UNKNOWN