BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROBLATE

    MDR report key: 3888453 · Received April 1, 2014

    Report

    Report Number
    3009970070-2014-00001
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    MONTERIS MEDICAL CORP
    Product Code
    GEX
    PMA / PMN Number
    K120561
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF OUR INVESTIGATION CONFIRMED THE SYSTEM HAD BEEN FUNCTIONING AS DESIGNED PRIOR TO THIS EVENT. THE MONTERIS MEDICAL CLINICAL SPECIALIST REPORTED THE FOOT PEDAL WAS DEPRESSED FOR MORE THAN 1 HOUR WITHOUT RELEASING THE PEDAL AND WHEN THE PEDAL WAS RELEASED, THE LASER CONTINUED TO FIRE. THE E-STOP WAS ENGAGED AND THE LASER STOPPED. THE CLINICAL SPECIALIST DETERMINED THAT SOME OF THE THERMAL COMPOUND ON THE SOLENOID HAD LEAKED INTO THE CAP, CAUSING THE PISTON ON THE SOLENOID TO STICK, CAUSING THE BELLOW TO STAY DEPRESSED AND THE LASER TO CONTINUE FIRING. THE SOLENOID AND CAP WERE REPLACED AND THE SYSTEM IS ACCEPTABLE FOR USE. THERE WAS NO HARM CAUSED TO THE PATIENT BECAUSE THE SAFETY MECHANISMS IN PLACE WERE USED TO STOP THE SYSTEM AND DISCONTINUE THE LASER FROM FIRING.

    Description of Event or Problem · 1

    DURING TREATMENT, THE LASER WAS NOT DEACTIVATED UPON RELEASE OF FOOT PEDAL FOLLOWING A LONG TREATMENT SEQUENCE (OVER 400 MEASUREMENTS). THE EMERGENCY STOP SWITCH WAS ENGAGED TO DEACTIVATE THE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193423 NEUROBLATE POWERED LASER SURGICAL INSTRUMENT GEX MONTERIS MEDICAL CORP NB102-IM

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR