BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROBLATE OPTIC FULLFIRE LASER PROBE

    MDR report key: 9653473 · Received January 30, 2020

    Report

    Report Number
    MW5092650
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    August 26, 2019
    Report Date
    January 28, 2020
    Manufacturer
    MONTERIS MEDICAL CORP.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O GIRL WITH GELASTIC SEIZURES DUE TO A "6 X 8 MM T1 ISOINTENSE HYPOTHALAMIC MASS, MOST CONSISTENT WITH A HYPOTHALAMIC HAMARTOMA". PT HAD LASER INTERSTITIAL THERMAL THERAPY (LITT) ABLATION SURGERY ON (B)(6) 2019 TO REMOVE MASS. HER IMMEDIATE POSTOPERATIVE COURSE WAS STABLE. HER EARLY POST OPERATIVE NEUROLOGIC EXAM SHOWED A LEFT FACIAL DROOP AND LEFT UE MONOPARESIS. THE LEFT LEG WITHDREW TO PAIN, THE RIGHT ARM AND LEG HAVE SPONTANEOUS VOLITIONAL MOVEMENT. POST-OPERATIVELY FAMILY REPORTS CHANGES IN COGNITIVE AND BEHAVIOR TO INCLUDE LEFT MOTOR FUNCTION DECLINE AND BEHAVIORAL CHANGES INCLUDING HYPERACTIVITY, OVEREATING, AGGRESSIVE BEHAVIOR, AND URINARY INCONTINENCE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112418 NEUROBLATE OPTIC FULLFIRE LASER PROBE POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP. PROBE:SIZE 00, 2.2MM OD PROBE: 171M811
    112419 NEUROBLATE ROBOTIC PROBE DRIVER POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP. DRIVER: D131724

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Disability