BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULLFIRE SELECT DIFFUSE TIP PROBE

    MDR report key: 5851814 · Received August 5, 2016

    Report

    Report Number
    3009970070-2016-00013
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    July 6, 2016
    Report Date
    July 6, 2016
    Manufacturer
    MONTERIS MEDICAL CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K143457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE WAS INSPECTED UPON RETURN AND THE LENS WAS SEPARATED FROM SHAFT BUT THE LENS WAS CONFIRMED TO BE FULLY INTACT. THE MANUFACTURING RECORDS WERE REVIEWED AND CONFIRMED THIS PROBE PASSED ALL APPROPRIATE INSPECTION/TEST CRITERIA REQUIRED FOR COMMERCIAL RELEASE. THERE IS NO INDICATION OF NONCONFORMANCE TO SPECIFICATION IN THE MONTERIS DEVICE THAT CONTRIBUTED TO THIS SEPARATION. INITIAL INVESTIGATION SUGGESTS THIS EVENT MAY BE ATTRIBUTED TO AN UNANTICIPATED INTERACTION BETWEEN THE STRYKER DEVICE AND THE MONTERIS PROBE. MONTERIS PERSONNEL HAVE CONTACTED STRYKER REPRESENTATIVES REGARDING THIS COMPLAINT AND THE ONGOING INVESTIGATION.

    Description of Event or Problem · 1

    DURING A TUMOR ABLATION PROCEDURE, THE RESIDENT WAS REMOVING THE PROBE FROM PATIENT WHEN THE END OF THE PROBE TIP DETACHED. A SNAPPING SOUND WAS HEARD BY THE RESIDENT. WHEN THE PROBE WAS TAKEN OUT, IT WAS CLEAR THE END OF THE PROBE WAS NOT ATTACHED. DURING CLOSURE OF BURR HOLE, THE PROBE TIP WAS DISCOVERED IN THE PATIENT'S BURR HOLE UNDER THE STRYKER FSG MOUNT SYSTEM. THE PROBE TIP WAS REMOVED AND THE BURR HOLE CLOSED WITHOUT FURTHER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503851 FULLFIRE SELECT DIFFUSE TIP PROBE DIFFUSE TIP PROBE GEX MONTERIS MEDICAL CORPORATION FFS000-01 C7211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention