BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 2221487 · Received August 17, 2011

    Report

    Report Number
    1717344-2011-00707
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 29, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT UNIT WILL NOT BE RETURNED FOR EVAL. 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 LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON NOTED THAT UPON INSPECTION OF THE TROCAR SITES, THERE WAS A SMALL BURN ON THE PORT THROUGH WHICH THE SPATULA HAD BEEN PLACED TO ACHIEVE HEMOSTASIS ON THE LIVER BED. THE BURNED SKIN ON THE RIGHT LATERAL PORT SITE WAS EXCISED AND THE TROCAR SITES WERE CLOSED. NO ADD'L INFO WAS MADE AVAILABLE BY THE SITE CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR