BEUDAMED
    FDA Enforcement Class II Terminated

    NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

    Recall: Z-2767-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2767-2015
    Event ID
    72015
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nico Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    FAX
    Report Date
    September 23, 2015
    Initiation Date
    July 29, 2015
    Classification Date
    September 15, 2015
    Termination Date
    September 22, 2015
    Address
    250 E 96th St, ste 125, Indianapolis, IN, 46240-3781, United States

    Description

    NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

    Reason

    Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. One type of malfunction may result in unexpected aspiration increase.

    Code Info

    Model number NN-7000 SN: 00231, 00232, 00242, 00245, 00248, 00250

    Distribution

    US Distribution to states of: MD, IN, CA, and NC.

    Quantity

    6 units