BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 3131575 · Received May 17, 2013

    Report

    Report Number
    1717344-2013-00358
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Report Date
    April 18, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(4). THE UNIT WAS RETURNED AND THE REPORTED CONDITION OF THE PENCIL SELF ACTIVATION WAS NOT VERIFIED BY INFO STORED IN THE UNIT'S MEMORY AND WAS NOT DUPLICATED. THE INVESTIGATION FOUND THAT THE UNIT FUNCTIONS NORMALLY AND WITHIN SPEC. A REVIEW OF THE APPROPRIATE DEVICE HISTORY RECORDS INDICATE THAT THIS UNIT WAS UPGRADED AND WAS RELEASED MEETING ALL SPECS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE GENERATOR WAS IN USE WHEN AN ELECTROSURGICAL PENCIL ACTIVATED ON ITS OWN DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220094 FORCE FX-C GENERATOR ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNK IF PENCIL IS COVIDIEN OR NON-COVIDIEN