The U.S. Food and Drug Administration (FDA) has announced that Coviden plc initiated a voluntary class II recall of a medical device called the Duet TRS Single Use Loading Unit. This device might cause serious injury or death during surgery in the thoracic area.
Covidien Duet TRS Might Cause Serious Even Deadly Injuries
Surgeons use the Covidien Duet TRS Single Use Loading Unit (SULU) as a kind of cartridge for universal surgical stapler guns to suture organs or blood vessels shut. The Duet TRS comes in various sizes depending on which tissues surgeons intend to staple.
On January 16, 2012, the FDA issued a press release stating that Covidien had initiated a voluntary recall of the following Duet TRS products:
- DUET4535 – DUET TRS 45 3.5MM STRAIGHT SULU
- DUET4535A – DUET TRS 45 3.5MM ARTICULATING SULU
- DUET4548 – DUET TRS 45 4.8MM STRAIGHT SULU
- DUET4548A – DUET TRS 45 4.8MM ARTICULATING SULU
- DUET6035 – DUET TRS 60 3.5MM STRAIGHT SULU
- DUET6035A – DUET TRS 60 3.5MM ARTICULATING SULU
- DUET6048 – DUET TRS 60 4.8MM STRAIGHT SULU
- DUET6048A – DUET TRS 60 4.8MM ARTICULATING SULU
Covidien discovered that when these units were used in thoracic surgery, they caused 13 injuries and three fatalities. Since Covidien introduced the product in 2009, it has sold as many as 500,000 units, and Covidien believes that one-third of them were used in thoracic (abdominal) procedures. The Duet TRS might injure “adjacent anatomical structures” in a patient’s abdomen, which can lead to deadly post-surgical complications.
Covidien planned to revise the Duet TRS’s instructions to contraindicate use in thoracic procedures, and it placed a hold on its Duet TRS global inventory until its instructions can be changed.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers of the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Covidien Duet TRS lawsuit on your behalf if necessary.
If you believe a Covidien Duet TRS harmed you, contact RLG today.