Recall Z-1469-2013 ยท GCJ Laparoscope, General & Plastic Surgery
Covidien LP
Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF 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.
| Date | Jun 5, 2013 (initiated May 6, 2013) |
| Status | Terminated |
| Reason | Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity |
| Root cause | Device Design |
| 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) 962-988 |
| Quantity | 126925 units |
| 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 Afr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112349 | VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR Covidien, Formerly US Surgical A Divison of Tyco H, Sep 1, 2011 |