BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA FUSION MAGNETIC RETRIEVER SYSTEM

    MDR report key: 5004150 · Received August 12, 2015

    Report

    Report Number
    3003502395-2015-00028
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 21, 2015
    Manufacturer
    ATRICURE, INC.
    Product Code
    OCL
    PMA / PMN Number
    K113475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND SENT TO ATRICURE ENGINEERING FOR ANALYSIS. THE COMPLAINT WAS CONFIRMED THE MAGNET WAS DISLODGED FROM THE END OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP. THAT DURING AN MINIMALLY INVASIVE CASE, THE PRODUCTS MAGNET FELL OFF INTO THE PATIENT AND WAS RECOVERED AND REMOVED. THE SURGEON UTILIZED ANOTHER DEVICE TO PROCEED WITH THE PROCEDURE. THE PATIENT OUTCOME WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529290 COBRA FUSION MAGNETIC RETRIEVER SYSTEM COBRA FUSION MAGNETIC RETRIEVER SYSTEM OCL ATRICURE, INC. 001-700-003 13316-042314

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention