BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-8C GENERATOR (SHANGHAI)

    MDR report key: 3882819 · Received February 20, 2014

    Report

    Report Number
    3006451981-2014-00516
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    November 19, 2013
    Report Date
    November 22, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT UNIT HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. INITIAL REPORT SENT: (B)(4) 2013 UNDER MDR NUMBER 1717344-2013-01060.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PROCEDURE A SPARK OCCURED AND THE GAUZE CAUGHT ON FIRE. THE FIRE WAS EXTINGUISHED, THEN A POP WAS HEARD AND THE CABLE/CORD CONNECTED TO THE INSTRUMENT BROKE/SNAPPED APART. THERE WAS NO PT INJURY. THE FACILITY'S BIOMED CHECKED THE GENERATOR AND DID NOT FIND ANYTHING WRONG WITH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106894 FORCE FX-8C GENERATOR (SHANGHAI) ELECTROSURIGAL GENERATOR GEI COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR UNK CABLE