BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSK 10CM TC ELECTRODE

    MDR report key: 7529594 · Received May 21, 2018

    Report

    Report Number
    3006630150-2018-01767
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 21, 2018
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250011524
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: NA. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: CSK-TC10-3M LOT: 041617 DESCRIPTION: CSK 100 MM TC ELECTRODE WITH 3M CABLE. THERE WERE A TOTAL OF TWO ELECTRODES RETURNED: (1) CSK-TC10-3M, LOT N049 (1) CSK-TC10-3M, LOT 041617

    Description of Event or Problem · 1

    DEVICE ANALYSIS WAS PERFORMED ON THE TWO RETURNED ELECTRODES FOUND THAT THE SHAFT WAS COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE SHAFTS WERE NOT RETURNED FOR ANALYSES. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373107 CSK 10CM TC ELECTRODE PROBE, RADIOFREQUENCY LESION GXI COSMAN MEDICAL CSK-TC10-3M N049 00813250011524

    Patients

    Seq Age Sex Outcome Treatment
    1