BEUDAMED
    FDA Recall Terminated

    LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .

    Recall: Z-1840-2019 · Initiated April 23, 2019

    Recall

    Recall Number
    Z-1840-2019
    Event Number
    82821
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HGI
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 23, 2019
    Terminated
    April 24, 2020
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .

    Reason

    2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.

    Action

    On April 23, 2019, the firm distributed Urgent Medical Device Safety Alert letters to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to immediately discontinue use of the discrepant product, quarantine the product, and replace the 2 main fuses with the 2 fuses provided with the firm's mailing. Customers were provided with instructions to replace the fuses. Once customers have successfully completed the fuse replacement, they are asked to complete the Acknowledgement and Receipt form and return it to CooperSurgical. If you have any questions, please contact the firm at 203-601-5200 ext. 3300.

    Distribution

    US Nationwide Distribution in the states of CA, CT, IN, MA, MI, MN, NC, NV, NY, OH, TX, WA and WI.

    Quantity

    19