BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONTERIS NEUROBLATE

    MDR report key: 9805044 · Received March 9, 2020

    Report

    Report Number
    9805044
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    December 16, 2019
    Report Date
    January 21, 2020
    Manufacturer
    MONTERIS MEDICAL CORP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ATTEMPTED LEFT STEREOTACTIC BRAIN BIOPSY WITH LEFT LASER INTERSTITIAL THERMAL ABLATION, THE LASER WAS NOT OPERATIONAL DESPITE MULTIPLE ATTEMPTS TO FIX BY OUR MONTERIS REPRESENTATIVE. AFTER INVESTIGATION, THE FAILURE OCCURRED DUE TO CIM PCM (PROTECTION CIRCUIT MODULE) ASSEMBLY WAS NOT SUPPLYING 24 VOLTS TO THE LASER DEVICE, SIGNAL CONDITIONER AND OTHER DEVICES. THE PROCEDURE WAS ABORTED. THERE WAS NO HARM TO THE PATIENT. THE PATIENT WILL BE RESCHEDULED FOR SURGERY AFTER LASER REPAIRS ARE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272313 MONTERIS NEUROBLATE POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP 20120

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA