UK MHRA has issued a Medical Device Alert (MDA) relating to certain of Covidien’s LigaSure Dolphin Tip sealer dividers, following up on the company’s own Field Safety Notice(FSN) issued last November (2011). The full MDA can be found here.
According to the MDA the handle pins on this disposable device may disengage(pictured), “possibly compromising the removal of tissue from between the jaws”. In other words, difficulty disengaging the jaws from the target tissue (as written rather more clearly in the original FSN, which can be found here.
In an open procedure there is an additional risk that the disengaged handle pin may fall into the patient cavity and remain unnoticed.
Two part numbers are included in the MDA. These are LS1500 and LS1520. Specific LOT numbers have been identified as at risk as follows:
LS1500: S1CB001 through S1JB048X
LS1520: S1CB010X through S1HB013P
What to do
Check inventory, quarantine affected product and follow instructions included on the FSN for return of the goods to Covidien.