Device product
Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH 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.
Z-1471-2013
Product summary
- Firm
- Covidien LP
- Event
- Event 65093
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2705 units
- Official record key
device-enforcement:Z-1471-2013
Official wording
Reason: Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
Code information: Lot Numbers: N2J0315X through N3A0389X Note: The specific lot numbers listed below are not affected by this recall and are acceptable for use: N2H0045X,N2H0166X,N2H0286X, N2H0357X,N2 H051 6UX
Distribution pattern: 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
Derived failure modes
-
Unknown
Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity