Intuitive Surgical, maker of the da Vinci Surgical robot, has issued an “urgent medical device notification.” They are announcing that certain -09 and -10 versions of the MCS instruments may develop micro-cracks near the distal (scissor) end of the shaft following reprocessing. The micro-cracks may create a pathway for electrosurgical energy to leak to tissue during use and potentially cause internal burns.
The following products are affected:
- Part Number: 420179-09 and -10 Description: 8 mm Monopolar Curved Scissors (Hot Shears)
- Part Number: 400179-09 and -10 Description: 8 mm Monopolar Curved Scissors (Hot Shears)
The company has issued a statement claiming that with more than a million surgeries to date, there has been no confirmed evidence of patient injury attributable to this issue.
Okay, fair enough. But lots of other injuries have been caused by the de Vinci robot and this is just one more example – as if we needed another one – that this product was just not ready for the market.
This is technically not a recall. Someone explain to me why it is not considered a recall? I bet the FDA weighs in or it at some point with a different view.
If you believe that you have been injured during a da Vinci robotic surgery, call us toll-free at 1.800.553.8083, or online.