BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLATOR TRANSPOLAR

    MDR report key: 1728728 · Received June 17, 2010

    Report

    Report Number
    1728728
    Event Type
    Malfunction
    Date Received
    June 17, 2010
    Date of Event
    April 9, 2010
    Report Date
    June 17, 2010
    Manufacturer
    ATRICURE, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    UNABLE TO PLUG IN HANDPIECE TO ATRICURE MACHINE, ONE PRONG OF THE ATTACHMENT TIP IS BENT. THE PRODUCT HAD NO PATIENT CONTACT AT ALL. IT WAS BENT RIGHT OUT OF THE PACKAGING. ====================== MANUFACTURER RESPONSE FOR SURGICAL ABLATION SYSTEM, ISOLATOR======================PRODUCT IS BEING SENT AND THEY WILL SHIP A REPLACEMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLATOR TRANSPOLAR SURGICAL ABLATION SYSTEM GEI ATRICURE, INC * 21928

    Patients

    Seq Age Sex Outcome Treatment
    1 *