BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6625521 · Received June 8, 2017

    Report

    Report Number
    3006630150-2017-01952
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    May 17, 2017
    Report Date
    May 17, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10, LOT #: 101716, DESCRIPTION: NITINOL TC ELECTRODE, 100 MM QUANTITY: 5. MODEL #: TCN-10, LOT #: 122316, DESCRIPTION: NITINOL TC ELECTRODE, 100 MM QUANTITY: 3.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10-3M LOT #: 101716 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM WITH 3M CABLE QUANTITY: 5 MODEL #: TCN-10-3M LOT #: 122316 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM WITH 3M CABLE QUANTITY: 3 THERE WERE A TOTAL OF EIGHT ELECTRODES ANALYZED. DEVICE EVALUATION OF TCN-10 (LOT 122316 X QUANTITY 3) AND TCN-10-3M (LOT 101716 X QUANTITY 3) ELECTRODE EPOXY ARE DISCOLORED AND HAVE SMALL CHIP AWAY. TCN-10-3M (101716 X QUANTITY 1) ELECTRODE EPOXY IS DISCOLORED AND IT HAS DARK SPOTS NEAR THE SHAFT. TCN-10-3M (101716 X QUANTITY 1) ELECTRODE EPOXY IS DISCOLORED AND IT HAS A YELLOW PATCH NEAR THE SHAFT. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES, THE EPOXY BECOMES BRITTLE AND DISCOLORED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A MEDICAL FACILITY HAS MULTIPLE ELECTRODES THAT ARE SEEPING BLOOD OUT OF THE HUB. THE FACILITY CLEANS THE ELECTRODES BY SOAKING THEM IN ENZYMATIC FLUID AND USING A SOFT BRISTLE BRUSH TO REMOVE ANY TISSUE OR BLOOD FROM THE HUB PRIOR TO STERILIZATION. THE ELECTRODES WERE STERILIZED IN A PEEL PACK USING AN AUTOCLAVE AT 272 DEGREES FOR 4 MINUTES AND DRIED FOR 30 MINUTES. THE FACILITY PERFORMS AN AVERAGE OF 5 PROCEDURES A WEEK.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A MEDICAL FACILITY HAS MULTIPLE ELECTRODES THAT ARE SEEPING BLOOD OUT OF THE HUB. THE FACILITY CLEANS THE ELECTRODES BY SOAKING THEM IN ENZYMATIC FLUID AND USING A SOFT BRISTLE BRUSH TO REMOVE ANY TISSUE OR BLOOD FROM THE HUB PRIOR TO STERILIZATION. THE ELECTRODES WERE STERILIZED IN A PEEL PACK USING AN AUTOCLAVE AT 272 DEGREES FOR 4 MINUTES AND DRIED FOR 30 MINUTES. THE FACILITY PERFORMS AN AVERAGE OF 5 PROCEDURES A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407432 NITINOL TC ELECTRODE ELECTRODES GXI COSMAN MEDICAL TCN-10-3M 101716

    Patients

    Seq Age Sex Outcome Treatment
    1