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Recall Observatory FDA recall evidence

Device product

Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C 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-1470-2013

May 06, 2013

Class II

Product summary

Firm
Covidien LP
Event
Event 65093
Status
Terminated
Classification
Class II
Quantity
5364 units
Official record key
device-enforcement:Z-1470-2013

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: N2J0211X through N3D0118X 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

    reason.no_named_rule · v1.0.0

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