BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR WITH VERSION 4.0.0 + 4.1.0

    MDR report key: 2415284 · Received January 10, 2012

    Report

    Report Number
    2953189-2012-00008
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    December 1, 2011
    Report Date
    January 4, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAS AN ISSUE WITH GENERATOR WITH VERSION 4.0.0 + 4.1.0. THE CUSTOMER STATES THAT THE RFG SHUT DOWN WHILE FINISHING THE LAST SEGMENT DURING A CASE. THE GENERATOR WAS POWERED DOWN, AND REBOOTED AT WHICH TIME IT WORKED. THE GENERATOR THEN SHUT DOWN AGAIN PERMANENTLY. THE CASE WS THEN FINISHED OUT WITH POLIDOCANOL. VEINS WERE CLOSED AND PATIENT SENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERATOR WITH VERSION 4.0.0 + 4.1.0 GENERATOR WITH VERSION 4.0.0 + 4.1.0 GXD COVIDIEN RFG2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN