BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX-C GENERATOR

    MDR report key: 2231283 · Received July 25, 2011

    Report

    Report Number
    1717344-2011-00617
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 21, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT UNIT HAS NOT BEEN RECEIVED FOR EVAL. IF THE GENERATOR IS RECEIVED OR 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 THE UNIT WAS SELF-ACTIVATING. THERE WAS NO PT INVOLVEMENT OR INJURY. THE SITE HAS NO ADD'L INFO.

    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 NA