BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSMAN TCN NITINOL RF PROBES

    MDR report key: 8912338 · Received August 19, 2019

    Report

    Report Number
    MW5089186
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 2, 2019
    Report Date
    August 5, 2019
    Manufacturer
    COSMAN MEDICAL, LLC
    Product Code
    GXI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STERILE PROCESSING REPORTED THAT THEY WERE UNABLE TO GET THE TCN NITINOL RF PROBES CLEAN; BLOOD REMAINED INSIDE THE PROBE. STERILE PROCESSING REPORTED THAT THE INTEGRITY OF THE SEAL WAS AFFECTED. PROBES TAKEN OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698836 COSMAN TCN NITINOL RF PROBES PROBE, RADIOFREQUENCY LESION GXI COSMAN MEDICAL, LLC TCN 10 23797361
    698837 COSMAN TCN NITINOL RF PROBES PROBE, RADIOFREQUENCY LESION GXI COSMAN MEDICAL, LLC TCN 10 22807295

    Patients

    Seq Age Sex Outcome Treatment
    1