BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROBLATE

    MDR report key: 3624948 · Received December 12, 2013

    Report

    Report Number
    3009970070-2013-00011
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    November 3, 2013
    Report Date
    December 12, 2013
    Manufacturer
    MONTERIS MEDICAL CORP
    Product Code
    GEX
    PMA / PMN Number
    K081509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING PROBE INSERTION A 3D MPRAGE MRI IMAGE WAS ACQUIRED AND THE PROBE WAS NOT SEEN IN THE TARGET. IT APPEARED TO HAVE SKIVED OFF OF THE DURA GOING INFERIOR TO THE CEREBELLUM AND NEVER ENTERED THE CEREBELLAR CORTEX. THE DURA WAS OPENED IN THE OPERATING ROOM PRIOR TO PT TRANSPORT TO THE MRI USING A SPINAL NEEDLE, TEST PROBE INSERTED, AND A BIOPSY WAS ALSO PERFORMED IN WHICH NO RESISTANCE WAS SEEN. THE PROBE WAS REMOVED AND REINSERTED INTO THE CORTEX AND THE ABLATION PROCEDURE PROCEEDED WITHOUT ANY ADDITIONAL INCIDENTS. NO INTERVENTION WAS NECESSARY AND THE PHYSICIAN STATED TWO WEEKS LATER THAT THE PT WAS DOING VERY WELL AND THE LESION WAS ACTUALLY NECROSIS WITH NO ACTIVE TUMOR CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651323 NEUROBLATE GEX - POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP 20050-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR