BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6819185 · Received August 24, 2017

    Report

    Report Number
    3006630150-2017-03201
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    August 21, 2017
    Report Date
    August 21, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250017502
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NA ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10-3M LOT #: 030515 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, WITH 3M CABLE.

    Description of Event or Problem · 1

    DEVICE EVALUATION FOR THE RETURNED ELECTRODES REVEALED THAT THE EPOXY WAS DISCOLORED AND HAD A CHIP OUT. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES THE EPOXY BECOMES BRITTLE AND DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597076 NITINOL TC ELECTRODE ELECTRODES GXI COSMAN MEDICAL TCN-10-3M 060215 00813250017502

    Patients

    Seq Age Sex Outcome Treatment
    1