BEUDAMED
    FDA Recall Terminated

    LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120

    Recall: Z-2057-2019 · Initiated June 18, 2019

    Recall

    Recall Number
    Z-2057-2019
    Event Number
    83100
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HGI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 18, 2019
    Terminated
    June 15, 2020
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120

    Reason

    The products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.

    Action

    The firm notified customers of the recall via Urgent Medical Device Recall letters dated June 18, 2019. Customers were informed that the device may fail to cut, coagulate, or blend tissue with use of the Foot Pedal. Serious injuries could occur due to this failure mode. Customers were instructed to do the following: - Use the Hand-Switch Pencil and Cord (Part Numbers: 395310/LP50101) to activate the cut, coagulation, or blend functions by hand control instead of foot action using the Foot Pedal. - Complete the acknowledgement and receipt form and return to the firm. If you have additional questions, please contact a CooperSurgical Product Surveillance representative at 203.601.5200 Ext. 3300 or email [email protected].

    Distribution

    Nationwide domestic distribution. International distribution to Canada and Costa Rica.

    Quantity

    358