BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROBLATE

    MDR report key: 3528218 · Received December 12, 2013

    Report

    Report Number
    3009970070-2013-00008
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    November 20, 2013
    Report Date
    January 22, 2014
    Manufacturer
    MONTERIS MEDICAL CORP
    Product Code
    GEX
    PMA / PMN Number
    K120561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    AT THE BEGINNING OF THE PROCEDURE, THE PHYSICIAN FOLLOWED NORMAL PROCEDURES TO OPEN THE DURA PRIOR TO DILATION, PERFORMANCE OF A BIOPSY AND PROBE INSERTION. THE PHYSICIAN FIRST USED A BIPOLAR TO CAUTERIZE THE TISSUE AND THEN USED A SIZE 11 BLADE TO OPEN UP THE DURA. THE DILATOR WAS INSERTED INTO THE CORTEX AND A BIOPSY OBTAINED WITHOUT INCIDENT. THE TEST PROBE WAS USED TO CHECK THE CLEARANCE OF THE SKULL BURR HOLE PRIOR TO PROBE INSERTION. FOLLOWING PROBE INSERTION A 3D MPRAGE MRI IMAGE WAS ACQUIRED AND IT WAS NOTICED THAT THE PROBE HAD SKIVED OFF THE DURA INSTEAD OF ENTERING THE CORTEX, WHICH CAUSED AN EPIDURAL HEMATOMA LATERAL TO THE BURR HOLE. THE PROBE WAS REMOVED AND REINSERTED INTO THE CORTEX AND THE ABLATION PROCEDURE PROCEEDED WITHOUT ANY ADD'L INCIDENTS. THE HEMATOMA WAS MONITORED THROUGHOUT THE PROCEDURE AND NO ADD'L INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651559 NEUROBLATE GEX - POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP 20368-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other