BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROBLATE

    MDR report key: 6673296 · Received June 28, 2017

    Report

    Report Number
    6673296
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 9, 2017
    Report Date
    June 12, 2017
    Manufacturer
    MONTERIS MEDICAL CORP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE ATTEMPTED, UNABLE TO COMPLETE FIBER ABLATION PORTION OF THE PROCEDURE DUE TO BREAKAGE OF THE FIBER TIP. PATIENT TRANSFERRED OUT OF MRI AND BACK INTO OPERATING ROOM (OR). PATIENT REPOSITIONED FOR OPEN CRANIOTOMY. LASER FIBER AND BROKEN TIP WERE REMOVED AND SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454644 NEUROBLATE POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP NBP-000-01

    Patients

    Seq Age Sex Outcome Treatment
    1