BEUDAMED
    FDA Recall Terminated

    AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.

    Recall: Z-1814-2017 · Initiated March 7, 2017

    Recall

    Recall Number
    Z-1814-2017
    Event Number
    76769
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    GWG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 7, 2017
    Posted
    March 20, 2017
    Terminated
    February 16, 2018
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.

    Reason

    Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.

    Action

    On March 15, 2017, 16 facilities and 1 Sales Rep were sent an Urgent Medical Device Recall Notification letter. Letters were sent Fed-Ex overnight. Customers were asked to immediately discontinue use and quarantine the product. A Sales Representative will remove the affected product and return to Aesculap Inc.

    Distribution

    Product was distributed throughout the United States and Canada.

    Quantity

    21 units distributed in U.S.