BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFE STYLET, 6F, 12 CM (W/ATTACHED CABLE)

    MDR report key: 2435835 · Received January 26, 2012

    Report

    Report Number
    2953189-2012-00022
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 13, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2011 THAT A CUSTOMER HAD AN ISSUE WITH RFS STYLET, 6F, 12 CM (W/ATTACHED CABLE). THE CUSTOMER STATES THAT THE IMPEDANCE READINGS ON THE GENERATOR WERE SHOWING INACCURATE INFO. THE DR VIEWED THE ULTRASOUND AND HE COULD SEE THAT HE THOUGHT WAS HEAT COMING FROM THE SIDE OF THE CATHETER. WHEN THE DR PULLED THE CATHETER OUT OF THE BODY, IT HAD A HOLE ON THE SIDE OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RFE STYLET, 6F, 12 CM (W/ATTACHED CABLE) RFE STYLET, 6F, 12 CM (W/ATTACHED GEI COVIDIEN RFS2-6-12 550799

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK