BEUDAMED
    FDA Adverse Event Other Summary report: N

    PMO COMBINED PROBE CONTAIING BOTH OXYGEN AND TE

    MDR report key: 1527018 · Received November 10, 2009

    Report

    Report Number
    9617494-2009-00008
    Event Type
    Other
    Date Received
    November 10, 2009
    Date of Event
    March 20, 2009
    Report Date
    November 10, 2009
    Manufacturer
    GMS-GESELLSCHAFT FUR MEDIZINISCHE
    Product Code
    DRF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED ONE COMBINED PO2 AND TEMPERATURE-PROBE REF CC1. P1 FOR INVESTIGATION. THE PROBE WAS RETURNED INSIDE ITS PROTECTIVE SLEEVE. THE PRODUCT WAS NOT DAMAGED BY KINKING OR BENDING. THE PROBE TUBE WAS FOUND TO HAVE BEEN SQUEEZED AT A DISTANCE OF ABOUT 20MM FROM THE PROBE TIP. DUE TO THIS COMPRESSION, THE PROBE TUBE WAS TORN IN AT THIS POSITION. THE PROBE TIP WAS OBSERVED TO BE ELONGATED. IN EVAL THE PO2-VALUES, VALUES THAT WERE MEASURED WERE WITHIN SPEC. ON A REVIEW OF COMPLAINT FILES, IT WAS DETERMINED THAT THIS EVENT HAS NOT BEEN REPORTED PREVIOUSLY BY INTEGRA. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PRODUCT WAS USED IN A BREAST RECONSTRUCTION PROCEDURE. IT DISPLAYED HIGHER VALUES THAN EXPECTED (385 MMHG). AS A RESULT, THERE WAS AN INCREASE IN SURGERY TIME OF ABOUT ONE HOUR. THIS PRODUCT'S INTENDED USE IS FOR BRAIN TISSUE OXYGEN MONITORING. THE DEVICE IS NOT INDICATED FOR THE PROCEDURE IN WHICH IT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PMO COMBINED PROBE CONTAIING BOTH OXYGEN AND TE NA DRF GMS-GESELLSCHAFT FUR MEDIZINISCHE 280808

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention