BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-8C GENERATOR

    MDR report key: 2241598 · Received September 2, 2011

    Report

    Report Number
    1717344-2011-00801
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A BREAST SURGERY, THE SURGEON NOTICED A BURN THAT WAS LOCATED 1CM FROM THE AREA WHERE THE SURGEON HAD MADE AN INCISION. THE BURN WAS DESCRIBED AS BEING 1CM X 2CM IN SIZE. THE INFO CONCERNING THE DEGREE OF THE BURN AND TREATMENT OF THE BURN WERE NOT PROVIDED BY THE CUSTOMER. THE GENERATOR WAS EVALUATED BY THE SITE BIOMEDICAL ENGINEER AND TESTED SATISFACTORILY. THE CUSTOMER DOES NOT BELIEVE THE UNIT CONTRIBUTED TO THE PT RECEIVING A BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX-8C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK REUSABLE PENCIL: E-2100, LOT #UNK