BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3CM GUIDED COAG DEVICE GEN 4

    MDR report key: 6115323 · Received November 18, 2016

    Report

    Report Number
    3003502395-2016-00164
    Event Type
    Injury
    Date Received
    November 18, 2016
    Report Date
    October 5, 2016
    Manufacturer
    ATRICURE INC.
    Product Code
    OCL
    PMA / PMN Number
    K120857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE WAS NOT RETURNED TO ATRICURE FOR EVALUATION AND DISPOSED OF BY THE HOSPITAL. THE LOT NUMBER OF THE DEVICE WAS UNABLE TO BE ASCERTAINED AND THERE WAS NO INDICATION OF A DEVICE DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    A SURGEON IN PARIS STATED HE HAD A PATIENT THAT HAD A DIAPHRAGMATIC HERNIA THAT TURNED TO BE A LIFE THREATENING SITUATION. PER INFORMATION RECEIVED ON 11 NOV 2016, THE PATIENT NECESSITATED AN EMERGENCY SURGERY AND EVENTUALLY RECOVERED WITH SOME PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762896 3CM GUIDED COAG DEVICE GEN 4 EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX OCL ATRICURE INC. EPI-SENSE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R