BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6642283 · Received June 14, 2017

    Report

    Report Number
    3006630150-2017-02122
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    May 26, 2017
    Report Date
    May 26, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10 LOT#: NI DESCRIPTION: NITINOL TC ELECTRODE, 100 MM QUANTITY: 73 MODEL #: TCN-15 LOT#: NI DESCRIPTION: NITINOL TC ELECTRODE, 150 MM QUANTITY: 15 MODEL #: TCN-5 LOT#: NI DESCRIPTION: NITINOL TC ELECTRODE, 50 MM QUANTITY: 7.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10 LOT#: 021916 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 5 MODEL #: TCN-10 LOT#: 111516 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 15 MODEL #: TCN-10 LOT#: 121716 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 8 MODEL #: TCN-10 LOT#: 013017 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 9 _ MODEL #: TCN-10 LOT#: 020916 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 5 MODEL #: TCN-10 LOT#: 121616 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 6 MODEL #: TCN-10 LOT#: 011117 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 4 MODEL #: TCN-10 LOT#: 120116 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 1 MODEL #: TCN-10 LOT#: 090916 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 9 MODEL #: TCN-10 LOT#: 021816 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 2 MODEL #: TCN-10 LOT#: 110916 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 1 MODEL #: TCN-15 LOT#: 020416 DESCRIPTION: NITINOL TC ELECTRODE, 150 MM TOTAL QUANTITY: 20 MODEL #: TCN-5 LOT#: 022616 DESCRIPTION: NITINOL TC ELECTRODE, 50 MM TOTAL QUANTITY: 6 MODEL #: TCN-5 LOT#: 011116 DESCRIPTION: NITINOL TC ELECTRODE, 50 MM TOTAL QUANTITY: 1 THE COMPLAINT REGARDING ELECTRODE TCN-10 LOT# 111516 THAT HAD ITS HUB SEPARATED FROM THE SHAFT WAS CONFIRMED. THE ROOT CAUSE WAS DUE TO THERMAL STRESS ASSOCIATED WITH AUTOCLAVE CYCLES AND EXTERNAL MECHANICAL FORCE EXERTED ON THE DEVICE. ALL OTHER TCN-10 ELECTRODES EXHIBITED CHIP OUTS AS WELL AS DISCOLORED EPOXY. ALL TCN-15 ELECTRODES EXHIBITED DISCOLORED EPOXY AND CHIP OUTS. THE ROOT CAUSE OF THIS FAILURE WAS DUE TO THERMAL STRESS ASSOCIATED WITH AUTOCLAVE CYCLES. ALL TCN-5 ELECTRODES EXHIBITED DISCOLORED EPOXY AND CHIP OUTS. THE ROOT CAUSE OF THIS FAILURE WAS DUE TO THERMAL STRESS ASSOCIATED WITH AUTOCLAVE CYCLES. THE COLOR OF NEWLY CURED EPOXY IS AMBER/LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES IT BECOMES BRITTLE AND DISCOLORED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10, LOT#: 021916, DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, QUANTITY: 2. MODEL #: TCN-10, LOT#: 111516, DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, QUANTITY: 3. MODEL #: TCN-10, LOT#: 121716, DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, QUANTITY: 1. MODEL #: TCN-10, LOT#: 013017, DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, QUANTITY: 2. MODEL #: TCN-15 ,LOT#: 020416 DESCRIPTION: NITINOL TC ELECTRODE, 150 MM, QUANTITY: 2. MODEL #: TCN-5, LOT#: 022616, DESCRIPTION: NITINOL TC ELECTRODE, 50 MM QUANTITY: 1.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE FACILITY HAD SEVERAL COMPROMISED ELECTRODES. THEY REPORTED THAT ONE OF THEM FELL APART AND THERE WAS BLOOD ON THE COMPONENTS WELL BELOW THE METAL CAP AND HUB. THE FACILITY IS CONCERNED ABOUT THE STERILITY OF THE ELECTRODES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE FACILITY HAD SEVERAL COMPROMISED ELECTRODES. THEY REPORTED THAT ONE OF THEM FELL APART AND THERE WAS BLOOD ON THE COMPONENTS WELL BELOW THE METAL CAP AND HUB. THE FACILITY IS CONCERNED ABOUT THE STERILITY OF THE ELECTRODES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE FACILITY HAD SEVERAL COMPROMISED ELECTRODES. THEY REPORTED THAT ONE OF THEM FELL APART AND THERE WAS BLOOD ON THE COMPONENTS WELL BELOW THE METAL CAP AND HUB. THE FACILITY IS CONCERNED ABOUT THE STERILITY OF THE ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423124 NITINOL TC ELECTRODE ELECTRODES GXI COSMAN MEDICAL TCN-10 021916

    Patients

    Seq Age Sex Outcome Treatment
    1