BEUDAMED
    FDA Recall Terminated

    Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.

    Recall: Z-1237-2018 · Initiated December 13, 2017

    Recall

    Recall Number
    Z-1237-2018
    Event Number
    79483
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 13, 2017
    Terminated
    April 14, 2020
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.

    Reason

    Product reportedly shutting down during use.

    Action

    The firm, Medtronic, sent a "Field Corrective Action Notice" dated 12/13/2017 to all consignees via Federal Express or certified mail on 12/13/17. The notice described the product, problem and actions to be taken. Customers were instructed to: immediately notify all users of Signia power handles of this important notification; follow the User manual and Instructions for Use; If your facility has distributed Signia" power handles to other persons or facilities, please promptly forward a copy of this letter to those recipients, and complete and return the Field Corrective Action Acknowledgement Form via Fax to (203) 492-7719 or email to: [email protected]. All in-control inventory and product at customers locations will have the software update installed. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

    Distribution

    Worldwide Distribution: US (Nationwide).

    Quantity

    2121