BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 1023305 · Received April 1, 2008

    Report

    Report Number
    1717344-2008-00095
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 7, 2008
    Manufacturer
    COVIDIEN (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FORCETRIAD WAS CHECKED BY THE SITE AND FOUND TO BE OPERATING NORMALLY. IT WAS PUT IN SERVICE FOR AWHILE BUT THEN REMOVED WHEN THE PT COMPLAINED ABOUT POST-OPERATIVE PROBLEMS. A REQUEST FOR RETURN OF THE DEVICE HAS BEEN MADE BUT TO DATE THE UNIT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT AT THE BEGINNING OF A LAPAROSCOPIC TUBAL LIGATION PROCEDURE, THE SURGEON HAD PLACED ONE TROCAR WITH A CAMERA, THEN PLACED THE TROCAR IN WHICH HE INSERTED THE BIPOLAR HANDPIECE, A KEIR SURGICAL BIPOLAR HANDPIECE AND BIPOLAR CORD. HE GRASPED THE TUBES, AND THEN HEARD THE BIPOLAR BEING ACTIVATED WITHOUT THE FOOT-PEDAL BEING PRESSED BY HIM. THE SURGEON IMMEDIATELY REMOVED THE BIPOLAR HANDPIECE FROM THE TROCAR. THE SURGEON SAID THAT EVEN WHEN THE BIPOLAR HANDPIECE WAS OUTSIDE OF PT'S BODY, THE BIPOLAR HANDPIECE BECAME ACTIVATED BY ITSELF FOR A FEW SECONDS, THEN STOPPED. THE SURGEON CALLED IN A GENERAL SURGEON TO CHECK IF THERE WAS ANY DAMAGED TISSUE. THEY NOTICED THERE WAS A SMALL BURN ON SEROSA OF JEJUNUM (SIZE APPROX. 1 CM X 2 MM). THE SURGEON REPORTED THAT THE PT FULLY RECOVERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization