Medical device manufacturer, Covidien Private Limited issued a medical device safety alert concerning Versaport Bladeless Optical 5mm Trocar with Fixation Cannula. The affected code number are ONB5LGF, ONB5SHF, ONB5STF, ONB5STF2C, ONBFCA5SH, ONBFCA5ST and the affected lot numbers range are N2H0414X through, N2H0413X through, N2H0353X through, N2J0211X through, N2J0315X through and N2J0150X through. The special lot numbers (N2H0045X, N2H0166X, N2H0286X, N2H0357X and N2H0516UX) are not affected by this recall and are acceptable for use.
Covidien has received reports of seals disengaging from the cannula which may result in a component inadvertently disengaging into the patient's cavity. No related adverse events have been reported at this time.
The seal is located within the trocar body itself and when defective, may detach from the trocar and be pushed by the laparoscopic instrument into the body cavity. If detected, the detached seal should be removed. As with all foreign bodies, if undetected and left free in the body, the seal may lead to a complication, the nature of which is undetermined.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 10 May 2013