Already facing mounting lawsuits related to its da Vinci Surgical System,
Intuitive Surgical recently initiated a voluntary recall to repair or
replace faulty instrument arms on certain robot-assisted surgery devices.
Our Philadelphia-based consumer class action
attorneys at Golomb & Honik, P.C. are dedicated to helping victims of dangerous medical devices pursue
the financial peace of mind they need to move forward with their lives.
If you or a loved one suffered injury that may have been related to the
use of a da Vinci Surgical System, please call
(215) 278-4449 for your free case evaluation; our accomplished lawyers welcome clients
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The recent da Vinci recall was intended to address potential problems with
the so-called Patient Side Manipulators (PSMs) on S, Si and Si-e model
da Vinci Surgical Systems. PSMs are the instrument arms of the robotic devices.
According to Intuitive Surgical's notice on the matter, excessive friction
within the instrument arms of certain affected models "could interrupt
smooth instrument motion." This interruption is felt as resistance
by the conducting surgeon; if the surgeon pushes through this resistance,
Intuitive says "the instrument could stall momentarily and then suddenly
catch-up to the correct position."
In its own notice, the U.S. Food and Drug Administration (FDA) categorized
the issue as a Class II recall, which means the PSM defect could result
in "temporary or medically reversible" complications if not
corrected. As for the da Vinci Surgical System itself, an increasing number
of lawsuits allege that use of the robotic devices in hysterectomies,
prostate surgeries and other surgical treatments has led to severe-and
Adverse effects associated with da Vinci devices include:
- Internal burns
- Internal tissue tears and punctured organs
- Hematomas (blood clots that form within tissue or organs as a result of
broken blood vessels)
- Fistulas (abnormal connections between organs)
- Sepsis (a potentially deadly whole-body inflammation caused by infection)