BEUDAMED
    FDA Recall Terminated

    Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

    Recall: Z-1467-2013 · Initiated May 6, 2013

    Recall

    Recall Number
    Z-1467-2013
    Event Number
    65093
    FEI Number
    1219930
    Product Code
    GCJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 6, 2013
    Posted
    June 5, 2013
    Terminated
    August 12, 2014
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

    Reason

    Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

    Action

    Covidien sent an Urgent Medical Device Recall letter dated May 6, 2013,via federal express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the product and return all inventory to Covidien Surgical Solutions, 195 McDermott Road, North Haven, CT 06473. Customers were requested to return completed Response Form. Customers with questions were instructed to contact their Covidien representative or Covidien Customer Service, Monday through Friday, Sam - 6:30pm ET, at (800) 962-9888, option 1, and then option 2. For questions regarding this recall call 203-492-8165.

    Distribution

    Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland Israel Italy Japan Kuwait Netherlands Norway Portugal QATAR Saudi Arabia Serbia Singapore South Africa Spain OMAN Sweden Switzerland UAE United Kingdom Venezuela

    Quantity

    2716 units