BEUDAMED
    FDA Adverse Event Other Summary report: N

    LICOX TEMPERATURE MICRO-PROBE

    MDR report key: 571073 · Received January 26, 2005

    Report

    Report Number
    9617494-2005-00003
    Event Type
    Other
    Date Received
    January 26, 2005
    Report Date
    January 26, 2005
    Manufacturer
    GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALL LOTS OF LICOX C8.B TEMPERATURE PROBES MANUFACTURED FOR DISTRIBUTION IN THE UNITED STATES ARE TESTED FOR PYROGENS PRIOR TO RELEASE FOR SALE. THE DEVICE MUST EXHIBIT AND ENDOTOXIN LEVEL OF LESS THAN 0.05 EU/ML (2.15 EU/DEVICE), AS THE PROBE COMES IN CONTACT WITH CEREBROSPINAL FLUID (CSF). DURING ROUTINE PYROGEN TESTING PRIOR TO RELEASE TO FINISH GOODS FOR DISTRIBUTION, SOME C8.B TEMPERATURE PROBES EXHIBITED ENDOTOXIN LEVELS ABOVE THE REQUIRED LIMIT. THESE LOTS HAD NOT BEEN RELEASED TO THE FIELD. AS A PRECAUTION, INTEGRA CONDUCTED ADDITIONAL RE-TESTING OF SAMPLES OF THE C8.B TEMPERATURE PROBES THAT HAD PASSED PYROGEN TESTING PRIOR TO DISTRIBUTION, WERE RELEASED FOR SALE, AND FOUND THAT SAMPLES FROM SEVEN LOTS HAD TEMPERATURE PROBES WHICH ALSO EXHIBITED INCREASED ENDOTOXIN LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LICOX TEMPERATURE MICRO-PROBE LICOX BRAIN TISSUE OXYGEN MONITORING SYS GWM GESELLSCHAFT FUR MEDIZINISCHE SONDENTECH * VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN